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Position Summary: Clinical Nurse Specialist Maternal Child Health Educator / NICU The Clinical Educator of Maternal Child - Registered Nurse(RN) plans, directs, coordinates, conducts, evaluates educational activities/programs and implements staff development, continuing education, orientation, annual update, and competency evaluation processes including remediation of staff in the assigned department(s). Educational activities include in-services, competency validation and are consistent with the mission, vision, goals, and specified service lines of Community Hospital of San Bernardino (CHSB). #DHNICULeader
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The incumbent primary responsibilities include ensuring an optional patient experience and quality care at the unit level. The incumbent will work under the direction of the Nursing Director and in partnership with the Medical Staff to coordinate the overall operation of the department to ensure optimal scheduling staffing levels and payroll outcomes are in effect and are based upon census, acuity and the budget. The incumbent is also responsible for ensuring sound financial Quailty and utilization oversight of operations. The incumbent incorporates differences into the provision of care and integrates knowledge, skills and experiences to meet the needs of patients and families with an awareness of cost containment and time management. In addition, the incumbent trains, evaluates and supervises staff in canying out department policies and procedures. The Incumbent provides supervision and performs delegated administrative functions on a Hospital-Wide basis during a specific shift. The incumbent has the authority to act on behalf of Administration and the Management team. The incumbent serves as a liaison, resource, and support person for an departments, and their personnel, physicians, patients and their families. The incumbent communicates with the Administrator On Call and/or the VPPCS as indicated. The MedSurge staff nurses , Administrative Coordinators and Certified Nursing Assistants will report to the incumbent. The incumbent will report to the Nursing Director.
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The incumbent primary responsibilities include ensuring an optional patient experience and quality care at the unit level. The incumbent will work under the direction of the Nursing Director and in partnership with the Medical Staff to coordinate the overall operation of the department to ensure optimal scheduling staffing levels and payroll outcomes are in effect and are based upon census, acuity and the budget. The incumbent is also responsible for ensuring sound financial Quailty and utilization oversight of operations. The incumbent incorporates differences into the provision of care and integrates knowledge, skills and experiences to meet the needs of patients and families with an awareness of cost containment and time management. In addition, the incumbent trains, evaluates and supervises staff in canying out department policies and procedures. The Incumbent provides supervision and performs delegated administrative functions on a Hospital-Wide basis during a specific shift. The incumbent has the authority to act on behalf of Administration and the Management team. The incumbent serves as a liaison, resource, and support person for an departments, and their personnel, physicians, patients and their families. The incumbent communicates with the Administrator On Call and/or the VPPCS as indicated. The MedSurge staff nurses , Administrative Coordinators and Certified Nursing Assistants will report to the incumbent. The incumbent will report to the Nursing Director.
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The Clinical Pharmacist provides clinical support and distribution services in coordination with physicians and nursing to deliver quality and cost effective drug therapy to patients. This position requires the full understanding and active participation in fulfilling the Mission of Community Hospital of San Bernardino. It is expected that the employee will demonstrate behavior consistent with the Core Values. The employee shall support Community Hospital of San Bernardino strategic plan and the goals and direction of the quality improvement, process, and activities.
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In keeping with the Dignity Health care philosophy, the Clinical Pharmacist-Regional Operations Specialist is responsible for the pharmaceutical care of patients within a patient care team, as well as drug therapy, control/analysis of prescriptions, drug monitoring, and remediation of any adverse side effects. They will attend multidisciplinary rounds and perform various clinical activities as deemed necessary by the pharmacy manager. They will promote rational drug therapy to providers to optimize patient outcomes, and minimize hospital costs wherever possible. Additionally, they will evaluate all clinical pharmacy services provided to adult patients at Marian Regional-Arroyo Grande Campus, Marian Regional-Santa Maria Campus, and French Hospital for areas of improvement and/or expansion of clinical services and ensure that clinical pharmacy practice related policies and procedures are current to best practice and abide by all federal and state regulations. They will also conduct routine continuous quality improvement data collection, develop applicable interventions, and ensure completion of projects. Promotes safe, effective use of pharmaceutical products and provides consultative and other support on an as needed basis.
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Position Summary:
Under the supervision of the Director of Rural Clinics, the incumbent functions as the Clinical Psychologist responsible for conducting brief psychological treatment with children, adolescents and families and participates in multidisciplinary clinics.
~LI-DH
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SUMMARY - Provides supervised psychological testing and scoring in the areas of cognitive skills, personality, academic achievement, occupational/vocational interests, etc. Provides written and verbal report of test results and behavioral observations to supervising psychologist. Assists staff psychologists in treating patients referred for certain types of cognitive and behavioral remediation.
The Department of Clinical Neuropsychology at Barrow Neurological Institute at St Joseph’s Hospital and Medical Center has 9 faculty/staff neuropsychologists and 5 post-doctoral residents. The selected individual will administer, score, and record neuropsychological tests according to guidelines and protocols under the supervision of a neuropsychologist and in collaboration with residents. The individual will provide written and verbal behavioral observations to the supervising neuropsychologist and/or resident. Duties may also include computerized test scoring and data entry. Good computer skills (at minimum including Microsoft Office suite) are required. In addition, the selected individual will be responsible for maintaining test supplies, performing basic statistical analyses, and assisting in subject recruitment for clinical trials.
**Seeking a Bilingual (English/Spanish) Clinical Psychometrist
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SUMMARY - Provides supervised psychological testing and scoring in the areas of cognitive skills, personality, academic achievement, occupational/vocational interests, etc. Provides written and verbal report of test results and behavioral observations to supervising psychologist. Assists staff psychologists in treating patients referred for certain types of cognitive and behavioral remediation.
The Department of Clinical Neuropsychology at Barrow Neurological Institute at St Joseph’s Hospital and Medical Center has 9 faculty/staff neuropsychologists and 5 post-doctoral residents. The selected individual will administer, score, and record neuropsychological tests according to guidelines and protocols under the supervision of a neuropsychologist and in collaboration with residents. The individual will provide written and verbal behavioral observations to the supervising neuropsychologist and/or resident. Duties may also include computerized test scoring and data entry. Good computer skills (at minimum including Microsoft Office suite) are required. In addition, the selected individual will be responsible for maintaining test supplies, performing basic statistical analyses, and assisting in subject recruitment for clinical trials.
**Seeking a Bilingual (English/Spanish) Clinical Psychometrist
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SUMMARY - Provides supervised psychological testing and scoring in the areas of cognitive skills, personality, academic achievement, occupational/vocational interests, etc. Provides written and verbal report of test results and behavioral observations to supervising psychologist. Assists staff psychologists in treating patients referred for certain types of cognitive and behavioral remediation.
The Department of Clinical Neuropsychology at Barrow Neurological Institute at St Joseph’s Hospital and Medical Center has 9 faculty/staff neuropsychologists and 5 post-doctoral residents. The selected individual will administer, score, and record neuropsychological tests according to guidelines and protocols under the supervision of a neuropsychologist and in collaboration with residents. The individual will provide written and verbal behavioral observations to the supervising neuropsychologist and/or resident. Duties may also include computerized test scoring and data entry. Good computer skills (at minimum including Microsoft Office suite) are required. In addition, the selected individual will be responsible for maintaining test supplies, performing basic statistical analyses, and assisting in subject recruitment for clinical trials.
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Job Summary:
Performs routine clinical research activities under the direction of the principal investigator, research nurse clinician, and research specialist. Collects information and reports data as requested.
Responsible for creating and maintaining accurate records and documentation. Assists with scheduling patients within required protocol windows. Obtains and processes specimens under direction of research nurse/coordinator. Follows established protocols for safe packing and shipping of hazardous materials.
Ensures study supplies are available and adequate. Ensures appropriate internal/external customer service by demonstrating professional interactions with Sponsor, study monitors and other departments. Ensures that the appropriate subject informed consent is obtained.
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SUMMARY - The Clinical Research Associate position will assist with overall project administration and provide clinical monitoring to oversee the progress of multi-center, investigator initiated, or industry sponsored studies. Clinical monitoring visits are conducted either onsite or remotely, and the CRA's role will ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), International Conference on Harmonization- Good Clinical Practice (ICH-GCP) guidelines, and all applicable regulatory requirements.
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The Ivy Brain Tumor Center is a non-conventional, non-profit program offering state-of-the-art clinical trials for patients with most aggressive form of brain cancer.
It is home to the largest collection of Phase 0 trials for brain tumor in the world. Our trials select patients with specific genetic signatures to receive a matched experimental treatment regimen prior to their scheduled brain tumor operation.
The Ivy Brain Tumor Center is currently recruiting a highly motivated and driven Clinical Research Biostatistician, preferably with experience, to join our team focusing
on cutting edge Phase 0/II clinical trials for brain tumors at BNI. The Biostatistician is responsible for applying the knowledge of statistics to assist with clinical study
design, protocol development and statistical analysis of the clinical studies. The Biostatistician will also review project related documents, prepare Statistical Analysis
Plans and statistical reports.
As part of the Research Team, the Biostatistician will play a key role with the Research Team and interface with external vendors to fulfill the responsibilities of biostatistics.
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Position Summary:
The Clinical Research Coordinator (CRC) works with the Dignity Health Research Institute Market Clinical Research Manager (MCRM), Principal Investigators, co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the Dignity Health Research Institute. The incumbent independently manages all aspects of multiple clinical trials or other research projects as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. The incumbent ensures compliance of the research program and its studies with all applicable federal and state regulations, as well as Dignity Health policy.
This positon is responsible for maintaining quality standards for responsive service and professional documentation in compliance with Dignity Health policies and procedures, and federal and state laws and regulations, all which is consistent with the Mission and Values of Dignity Health. This is an exempt position that may require occasional overnight travel and weekend assignments.
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Clinical Research Coordinator
Job Summary:
The Clinical Research Coordinator (CRC) works with the Dignity Health Research Institute Market Clinical Research Manager (MCRM), Principal Investigators, co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the Dignity Health Research Institute. The incumbent independently manages all aspects of multiple clinical trials or other research projects as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. The incumbent ensures compliance of the research program and its studies with all applicable federal and state regulations, as well as Dignity Health policy.
This positon is responsible for maintaining quality standards for responsive service and professional documentation in compliance with Dignity Health policies and procedures, and federal and state laws and regulations, all which is consistent with the Mission and Values of Dignity Health. This is an exempt position that may require occasional overnight travel and weekend assignments.
Mission:
Dignity Health and Sponsoring congregations are committed to furthering the healing ministry of Jesus. Resources are dedicated to: delivering compassionate, high-quality, affordable health services; serving and advocating for our sisters and brothers who are poor and disenfranchised; and collaborating with others in the community to improve the quality of life. As part of this mission Dignity Health desires to be a national leader in developing comprehensive research programs, infrastructure and resources to further our commitment to the delivery of the highest quality care and services while maintaining business integrity in all aspects of our operations.
Travel:
Occasional overnight travel to investigator meetings and to Dignity Health’s operating regions, corporate headquarters, Dignity Health facilities and corporate satellite offices.
Reporting Relationships:
This position reports directly to the Dignity Health Research Institute Market Clinical Research Manager and will have no direct reports.
Job Standards
- Mission and Commitment
- Conveys an image of dignity and trustworthiness. Respects the rights, privacy and differences of others. Demonstrates advocacy for vulnerable patient populations. Connects with resources available to assist the poor and vulnerable to provide patient care. Supports the rights of patients in the daily delivery of care. Uses time effectively. Utilizes supplies appropriately and participates in recycle and re-use programs. Follows safety policies for self and patients
- Teamwork and Collaboration
- Listens to others ideas, with willingness to be influenced 2) Functions well in teams 3) Gives common goals priority over individual goals 4) Relates with others in a positive manner so that maximum job results are produced. 5) Effectively uses verbal and legible written communication skills with others. This includes being able to read, write, speak and understand English.
- Customer / Patient Focus
- Performs in a manner that enhances customer service 2) Demonstrates the attitude that quality can always be improved 3) Explores alternatives for doing things better.
- Standards of Conduct
- Maintains patient privacy and confidentiality 2) Consistently follows regulatory, The Joint Commission, and hospital policy requirements relating to the release or access of protected health information 3) Performs duties in compliance with applicable hospital and HR policies and procedures, such as dress code and time and attendance
- Compliance Program
- Demonstrates adherence to the Standards of Conduct 2) Independently maintains required tests, licenses, certifications, competencies, employee health (TB screening, fit testing, etc.) and other job-related qualifications 3) Fulfills compliance educational requirements as directed by the Compliance Department or department management
- Environment of Care
- Maintains and adheres to Hospital policy and procedures as it relates to: 1) General safety 2) Fire safety 3) Hazardous materials 4) Patient safety 5) Infection control 6) Security management 7) Emergency preparedness 8) Equipment management 9) Utility systems and radiation safety
Performance Standards:
Incumbents in this position shall comply with all applicable laws and rules including the Dignity Health Standards of Conduct and Dignity Health policies and procedures that apply to his/her job responsibilities, seek guidance when in doubt, promptly report any potential or suspected violation of Dignity Health Standards of Conduct, Dignity Health policy or procedure or applicable laws/regulations and when requested, assist Dignity Health personnel in investigating all allegations of violation. When called upon, the incumbent shall assist in risk evaluation and work collaboratively with facility/entity leaders to implement, monitor and mitigate risk corrective pans outlined by the Compliance program.
Performance Expectations:
- Take responsibility for his/her own actions.
- Know and comply with applicable laws and rules, including applicable Federal health care program requirements, the Dignity Health Standard of Conducts and Dignity Health policies and procedures as they apply to his/her particular job responsibilities
- Seek guidance as provided in the Dignity Health Standard of Conduct and/or policies when in doubt about his/her responsibilities
- Refrain from involvement in illegal, unethical or otherwise improper acts
- Promptly report any potential or suspected violation of Dignity Health Standard of Conduct, Dignity Health policy or applicable laws or regulations
- As requested, assist Dignity Health personnel and authorized outside personnel in investigating all allegations of violations
- Meet training requirements within designated timelines assigned
- Understand and accept consequences for failure to comply with Dignity Health Standards of Conduct
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Clinical Research Nurse Associate
Job Summary:
The Clinical Research Nurse Associate (CRNA) works with the Dignity Health Research Institute Market Clinical Research Manager (MCRM), Principal Investigators, co- and sub-investigators, Clinical Research Nurse and/or Senior Clinical Research Nurse, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the Dignity Health Research Institute. S/he serves as clinical nursing knowledge role model in the care of research participants, performing clinical procedures and assessments of research participants that are appropriate within the RN scope of practice. In conjunction with the PI and other facility/clinic staff, s/he may provide direct patient care related to a research protocol.
Under the direction of the MCRM and/or Senior Clinical Research Nurse, the incumbent assists with clinical trial or other research project coordinator duties as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. Under the direction of the MCRM and/or Senior Clinical Research Nurse, the incumbent helps to ensure compliance of the research program and its studies with all applicable federal and state regulations, as well as Dignity Health policy.
This positon is responsible for maintaining quality standards for responsive service and professional documentation in compliance with Dignity Health policies and procedures, and federal and state laws and regulations, all which is consistent with the Mission and Values of Dignity Health. This is a non-exempt position that may require occasional overnight travel and weekend assignments.
Mission:
Dignity Health and Sponsoring congregations are committed to furthering the healing ministry of Jesus. Resources are dedicated to: delivering compassionate, high-quality, affordable health services; serving and advocating for our sisters and brothers who are poor and disenfranchised; and collaborating with others in the community to improve the quality of life. As part of this mission Dignity Health desires to be a national leader in developing comprehensive research programs, infrastructure and resources to further our commitment to the delivery of the highest quality care and services while maintaining business integrity in all aspects of our operations.
Travel:
Occasional overnight travel to investigator meetings and to Dignity Health’s operating regions, corporate headquarters, Dignity Health facilities and corporate satellite offices.
Reporting Relationships:
This position reports directly to the Dignity Health Research Institute Market Clinical Research Manager and will have no direct reports.
Job Standards
- Mission and Commitment
- Conveys an image of dignity and trustworthiness. Respects the rights, privacy and differences of others. Demonstrates advocacy for vulnerable patient populations. Connects with resources available to assist the poor and vulnerable to provide patient care. Supports the rights of patients in the daily delivery of care. Uses time effectively. Utilizes supplies appropriately and participates in recycle and re-use programs. Follows safety policies for self and patients
- Teamwork and Collaboration
- Listens to others ideas, with willingness to be influenced 2) Functions well in teams 3) Gives common goals priority over individual goals 4) Relates with others in a positive manner so that maximum job results are produced. 5) Effectively uses verbal and legible written communication skills with others. This includes being able to read, write, speak and understand English.
- Customer / Patient Focus
- Performs in a manner that enhances customer service 2) Demonstrates the attitude that quality can always be improved 3) Explores alternatives for doing things better.
- Standards of Conduct
- Maintains patient privacy and confidentiality 2) Consistently follows regulatory, The Joint Commission, and hospital policy requirements relating to the release or access of protected health information 3) Performs duties in compliance with applicable hospital and HR policies and procedures, such as dress code and time and attendance
- Compliance Program
- Demonstrates adherence to the Standards of Conduct 2) Independently maintains required tests, licenses, certifications, competencies, employee health (TB screening, fit testing, etc.) and other job-related qualifications 3) Fulfills compliance educational requirements as directed by the Compliance Department or department management
- Environment of Care
- Maintains and adheres to Hospital policy and procedures as it relates to: 1) General safety 2) Fire safety 3) Hazardous materials 4) Patient safety 5) Infection control 6) Security management 7) Emergency preparedness 8) Equipment management 9) Utility systems and radiation safety
Special Skills:
- Demonstrated ability to work independently yet collaboratively with all members of the research community including physicians/principal investigators, research team members, IRBs, hospital and clinic personnel, and sponsors of research.
- Knowledge base to provide clinical education to patients, families, and other staff, including patients who may have a terminal disease.
- Excellent interpersonal and communication skills, both verbal and written, required.
- Highly motivated and flexible, with the ability to adjust to rapidly changing priorities and new projects.
- Strong attention to detail and ability to multi-task, organize and prioritize multiple projects.
Essential Duties & Responsibilities:
- Serve as clinical nursing knowledge role model in the care of research participants.
- Perform clinical assessments of research participants, including blood pressure, heart and respiratory rates, brief physical exams, EKGs, and other clinical testing appropriate within the RN scope of practice, i.e., NIH Stroke Scale, NYHA and CCS class.
- Perform clinical procedures per research protocols, including blood draws, injections, and other procedures appropriate within the RN scope of practice.
- In conjunction with the PI and other facility/clinic staff, may provide direct patient care related to the research protocol.
- Report change in research participant condition to PI and appropriate personnel in a timely manner.
- With direction from MCRM and/or Senior Clinical Research Nurse, assist with the implementation of clinical trials and research projects that meet Dignity Health Research Institute (DHRI) and facility/clinic objectives, and ensure compliance with protocol and sponsor requirements and all aspects of U.S. Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations, as well as DHRI requirements.
- Assist with the preparation, submission and management of all required study regulatory documents, applications and forms, including but not limited to the applicable Institutional Review Board (IRB) application form(s), informed consent documents, 1572 forms, Conflict of Interest forms, and other forms as required by the sponsor, IRB, or Dignity Health.
- Attend local Dignity Health IRB and appropriate clinical department meetings, as needed, for presentation of new protocols for review.
- Participate in site initiation and other sponsor-required training for all protocols.
- Assist with recruitment, screening and enrolling participants in trials.
- To ensure protocol adherence, accurate data collection and billing compliance, instruct/advise Principal Investigator (PI) and other health care providers in the hospital/ clinic setting as to protocol-required tests and procedures to be conducted at each visit.
- Maintain research subject charts/binders to meet protocol requirements.
- Obtain PI signatures on all required study documents.
- With appropriate training, conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements.
- Assist with the coordination of all study-required visits, procedures, tests and activities to meet protocol requirements; schedule participant appointments with appropriate provider/facility.
- Perform timely and accurate collection and reporting of data in accordance with protocol and sponsor requirements, applicable laws, and institutional policies.
- Dispense study medication to research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff.
- Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations.
- Work with DHRI billing staff to ensure clinical trials are performed in accordance with Dignity Health requirements; complete Research Encounter Forms for all participant visits.
- Assist with the identification and reporting of all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and Dignity Health policy.
- Assist with the preparation for, and participate in, sponsor monitoring visits or internal/external audits; resolve queries and other findings promptly; prepare responses or corrective actions plans as needed.
- Interface with participants, physician investigators, sponsors of research, IRBs, DHRI administration, patient care coordinators and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions.
- Complete CRN activity reports accurately, and submit in a timely manner.
- Attend investigator/coordinator meetings as required by study sponsors.
- Flex work schedule as needed to accommodate participant visits, sponsor deadlines or program needs; work hours as needed--which may exceed 40 hours per week--based on workload and deadlines.
- Complete professional and clinical education annually.
- Meet all mandatory requirements of the position including mandatory training, classes, licensure/certification, employee health requirements, and adherence to Dignity Health's Code of Conduct.
- Other duties as assigned.
Performance Standards:
Incumbents in this position shall comply with all applicable laws and rules including the Dignity Health Standards of Conduct and Dignity Health policies and procedures that apply to his/her job responsibilities, seek guidance when in doubt, promptly report any potential or suspected violation of Dignity Health Standards of Conduct, Dignity Health policy or procedure or applicable laws/regulations and when requested, assist Dignity Health personnel in investigating all allegations of violation. When called upon, the incumbent shall assist in risk evaluation and work collaboratively with facility/entity leaders to implement, monitor and mitigate risk corrective pans outlined by the Compliance program.
Performance Expectations:
- Take responsibility for his/her own actions.
- Know and comply with applicable laws and rules, including applicable Federal health care program requirements, the Dignity Health Standard of Conducts and Dignity Health policies and procedures as they apply to his/her particular job responsibilities.
- Seek guidance as provided in the Dignity Health Standard of Conduct and/or policies when in doubt about his/her responsibilities.
- Refrain from involvement in illegal, unethical or otherwise improper acts.
- Promptly report any potential or suspected violation of Dignity Health Standard of Conduct, Dignity Health policy or applicable laws or regulations.
- As requested, assist Dignity Health personnel and authorized outside personnel in investigating all allegations of violations.
- Meet training requirements within designated timelines assigned.
- Understand and accept consequences for failure to comply with Dignity Health Standards of Conduct.
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Clinical Research Coordinator
Job Summary:
The Clinical Research Coordinator (CRC) works with the Dignity Health Research Institute Market Clinical Research Manager (MCRM), Principal Investigators, co- and sub-investigators, clinical and ancillary departments, IRBs, and industry or government sponsors of research to plan, coordinate, implement and complete clinical trials and other research projects managed by the Dignity Health Research Institute. The incumbent independently manages all aspects of multiple clinical trials or other research projects as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. The incumbent ensures compliance of the research program and its studies with all applicable federal and state regulations, as well as Dignity Health policy.
This positon is responsible for maintaining quality standards for responsive service and professional documentation in compliance with Dignity Health policies and procedures, and federal and state laws and regulations, all which is consistent with the Mission and Values of Dignity Health. This is an exempt position that may require occasional overnight travel and weekend assignments.
Mission:
Dignity Health and Sponsoring congregations are committed to furthering the healing ministry of Jesus. Resources are dedicated to: delivering compassionate, high-quality, affordable health services; serving and advocating for our sisters and brothers who are poor and disenfranchised; and collaborating with others in the community to improve the quality of life. As part of this mission Dignity Health desires to be a national leader in developing comprehensive research programs, infrastructure and resources to further our commitment to the delivery of the highest quality care and services while maintaining business integrity in all aspects of our operations.
Travel:
Occasional overnight travel to investigator meetings and to Dignity Health’s operating regions, corporate headquarters, Dignity Health facilities and corporate satellite offices.
Reporting Relationships:
This position reports directly to the Dignity Health Research Institute Market Clinical Research Manager and will have no direct reports.
Job Standards
- Mission and Commitment
- Conveys an image of dignity and trustworthiness. Respects the rights, privacy and differences of others. Demonstrates advocacy for vulnerable patient populations. Connects with resources available to assist the poor and vulnerable to provide patient care. Supports the rights of patients in the daily delivery of care. Uses time effectively. Utilizes supplies appropriately and participates in recycle and re-use programs. Follows safety policies for self and patients
- Teamwork and Collaboration
- Listens to others ideas, with willingness to be influenced 2) Functions well in teams 3) Gives common goals priority over individual goals 4) Relates with others in a positive manner so that maximum job results are produced. 5) Effectively uses verbal and legible written communication skills with others. This includes being able to read, write, speak and understand English.
- Customer / Patient Focus
- Performs in a manner that enhances customer service 2) Demonstrates the attitude that quality can always be improved 3) Explores alternatives for doing things better.
- Standards of Conduct
- Maintains patient privacy and confidentiality 2) Consistently follows regulatory, The Joint Commission, and hospital policy requirements relating to the release or access of protected health information 3) Performs duties in compliance with applicable hospital and HR policies and procedures, such as dress code and time and attendance
- Compliance Program
- Demonstrates adherence to the Standards of Conduct 2) Independently maintains required tests, licenses, certifications, competencies, employee health (TB screening, fit testing, etc.) and other job-related qualifications 3) Fulfills compliance educational requirements as directed by the Compliance Department or department management
- Environment of Care
- Maintains and adheres to Hospital policy and procedures as it relates to: 1) General safety 2) Fire safety 3) Hazardous materials 4) Patient safety 5) Infection control 6) Security management 7) Emergency preparedness 8) Equipment management 9) Utility systems and radiation safety
Performance Standards:
Incumbents in this position shall comply with all applicable laws and rules including the Dignity Health Standards of Conduct and Dignity Health policies and procedures that apply to his/her job responsibilities, seek guidance when in doubt, promptly report any potential or suspected violation of Dignity Health Standards of Conduct, Dignity Health policy or procedure or applicable laws/regulations and when requested, assist Dignity Health personnel in investigating all allegations of violation. When called upon, the incumbent shall assist in risk evaluation and work collaboratively with facility/entity leaders to implement, monitor and mitigate risk corrective pans outlined by the Compliance program.
Performance Expectations:
- Take responsibility for his/her own actions.
- Know and comply with applicable laws and rules, including applicable Federal health care program requirements, the Dignity Health Standard of Conducts and Dignity Health policies and procedures as they apply to his/her particular job responsibilities
- Seek guidance as provided in the Dignity Health Standard of Conduct and/or policies when in doubt about his/her responsibilities
- Refrain from involvement in illegal, unethical or otherwise improper acts
- Promptly report any potential or suspected violation of Dignity Health Standard of Conduct, Dignity Health policy or applicable laws or regulations
- As requested, assist Dignity Health personnel and authorized outside personnel in investigating all allegations of violations
- Meet training requirements within designated timelines assigned
- Understand and accept consequences for failure to comply with Dignity Health Standards of Conduct
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Job Summary:
The Project Manager will be responsible for providing oversight and leadership necessary for successful delivery of projects from initiation to implementation to close-out of assigned multi-center clinical research activities. The Project Manager is expected to effectively manage scope, schedule/timelines, budget, quality and resources of the assigned trial(s). Study management will also include outside clinical site management, vendor management, and study meeting planning and execution.
Responsibilities:
- Collaborate with project investigators and research sites to ensure targets are met for study start up, site activation, patient recruitment and enrollment.
- Develop and collaborate on clinical documents including protocol, informed consent forms, study manuals, source documentation templates, recruitment materials and other study tools.
- Provides coordination and support for clinical study data management, biostatistics, and participating clinical sites.
- Assist in safety management and reporting to Data and Safety Monitoring Boards, medical monitors, funding and regulatory agencies.
- Assist in study budget development and work closely with contracts team to develop CTAs with selected sites.
- Lead cross-functional teams in the timely execution of high quality clinical research projects leveraging knowledge, expertise, and risk mitigation while functioning as the principal liaison with internal and external project stakeholders.
- Manage study related regulatory documents and ensure the Trial Master File (TMF) is up to date and audit ready throughout the course of the study.
- If applicable oversee IND and local and central IRB applications and communication with regulatory agencies (FDA, Health Canada, etc.) for studies with investigator held INDs.
- Assist project sites with IRB submissions, maintenance of regulatory documents and responding to study related questions from sites, vendors and sponsors in a timely fashion.
- Track key performance metrics for progress reports, help develop presentations for scientific meetings, and assist in preparing publications.
- Plan, manage, execute and participate in all study team meetings both remote and in person.
- Travel to national and international professional meetings as needed.
- Oversee quality assurance procedures for the study including the review of monitoring plans and tracking and review of trip reports.
- Assist with protocol
- Work closely with Program Manager on financial tracking and assist in invoice generation and facilitate site payments.
- Take on additional tasks and responsibilities, as requested.
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Position Summary: The Clinical Research Regulatory Specialist is responsible and accountable for ensuring inpatient and outpatient research protocols are coordinated through the regulatory process at study start-up and through the life of the study. Principal Duties and Accountabilities:
- Job duties will include the review and preparation of site informed consent forms, collection and maintenance of regulatory documents, completion of Institutional Review Board (IRB) applications and modifications, tracking of IRB approvals, completion of continuing review reporting, and preparation and assistance with internal and sponsor monitoring visits.
- Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards according to FDA, ICH, GCP guidelines is required.
- This position interacts with a variety of customers, both internal and external, requiring exceptional communication skills.
- The ability to multi-task and remain organized in a high volume clinical trial setting is required.
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Position Summary: The Clinical Research Regulatory Specialist is responsible and accountable for ensuring inpatient and outpatient research protocols are coordinated through the regulatory process at study start-up and through the life of the study. Principal Duties and Accountabilities:
- Job duties will include the review and preparation of site informed consent forms, collection and maintenance of regulatory documents, completion of Institutional Review Board (IRB) applications and modifications, tracking of IRB approvals, completion of continuing review reporting, and preparation and assistance with internal and sponsor monitoring visits.
- Demonstrated knowledge and understanding of human research policies, regulations, procedures and standards according to FDA, ICH, GCP guidelines is required.
- This position interacts with a variety of customers, both internal and external, requiring exceptional communication skills.
- The ability to multi-task and remain organized in a high volume clinical trial setting is required.
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Job Summary:
Ensures all appropriate subject consents are obtained. Collects and processes protocol required specimens. Acts as a liaison between Sponsor, Investigator, and Study Subject. Collects all required study data and completes CRFs in a timely, accurate manner. Ensures study documents are maintained in compliance with applicable regulations, guidelines, and policies (i.e. FDA, OHRP, IRB). Collaborates with Investigator to identify adverse events/ serious adverse events to ensure study subject safety and accurate and timely reporting. Ensures appropriate internal and external customer service by demonstrating professional interactions with Sponsor, study monitors, and other departments. Complies with all regulatory and policy requirements. Demonstrates knowledge of federal and state regulations, guidelines, and policies governing the conduct of clinical trials.
