The Clinical Research Nurse (CRN) 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 has responsibility for the oversight of studies that explore complex medical diseases, which involve specialty and subspecialty expertise. 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.
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 works with the MCRM 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 an exempt position that may require occasional overnight travel and weekend assignments.
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.
- Understanding of the ethical principles, culture and values of medical research.
- Critical thinking skills, decisive judgment and the ability to work with minimal supervision.
- 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.
- Demonstrated ability to perform all research coordination duties for multiple clinical trials simultaneously.
- 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.
- Demonstrated success in identifying and bringing in new trials and growing a research site’s volume.
- Strong attention to detail and ability to multi-task, organize and prioritize multiple projects.
- Ability to formulate logical and objective conclusions and make recommendations for effective solutions.
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 minimal guidance, implement 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 Market Clinical Research Manager (MCRM), PI, sponsors/CROs in identifying and evaluating potential new trials for feasibility of implementation at the site; provide recommendations. Complete clinical portions of sponsors’ feasibility questionnaires.
- Prepare, manage and submit all required any 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.
- Coordinate and participate in site initiation and other sponsor-required training for all protocols.
- Determine effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. Actively recruit, screen and enroll 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.
- Create source documentation forms/templates to ensure accurate collection of all study data; maintain research subject charts/binders to meet protocol requirements.
- Obtain PI signatures on all required study documents.
- Conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements.
- Coordinate 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.
- Identify and report 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.
- Prepare for, coordinate and participate in sponsor monitoring visits or internal/external audits; resolve queries and other findings promptly; prepare responses or corrective actions plans as needed.
- Serve as liaison between 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.
- Occasional overnight travel to investigator meetings and to Dignity Health’s operating regions, corporate headquarters, Dignity Health facilities and corporate satellite offices.
This position reports directly to the Dignity Health Research Institute Market Clinical Research Manager and will have no direct reports.
- 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
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.
- 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