Division Manager Clinical Research

Job ID
2021-160070
Employment Type
Full Time
Department
Research - Other
Hours / Pay Period
80
Facility
CHI National Office
Shift
Day
Standard Hours
Monday-Friday (8:00am - 5:00pm)
Work Schedule
CHI Not Applicable
Location
KY-LEXINGTON

Overview

CommonSpirit Health was formed by the alignment of Catholic Health Initiatives (CHI) and Dignity Health. With more than 700 care sites across the U.S. & from clinics and hospitals to home-based care and virtual care services CommonSpirit is accessible to nearly one out of every four U.S. residents. Our world needs compassion like never before. Our communities need caring and our families need protection. With our combined resources CommonSpirit is committed to building healthy communities advocating for those who are poor and vulnerable and innovating how and where healing can happen both inside our hospitals and out in the community.

 

Clinical Research Division Manager (CRDM) reports to the System Manager Clinical Research Operations of CommonSpirit Health Research Institute (CSHRI), regarding all site operations, research engagements, and community research program development. This position will provide local leadership as well as day to day supervision for all clinical trial activities and site based clinical research staff within their assigned divisions’ research sites. This position works closely with essential research constituencies (e.g. Investigators, research staff, and other internal and external research-related parties as needed to ensure the efficient and compliant initiation, ongoing administrative management, and support of research. Facilitates the general pre-award and post award clinical trial management workflow.  Develops and establishes recommendations for changes in work operations.  

Responsibilities

  • Serve as a central point of contact for and liaison to the research community to provide guidance related to the initiation and ongoing conduct of all clinical research.
  • Generate local support for research activities, including maintaining visibility with local leaders, physicians and other clinicians, and patients regarding research opportunities and portfolio.
  • Accountable for all site research activities including adherence to GCP guidelines, site timelines, quality control and assurance of clinical trial data collection, clinical trial drug/device management, and research staff training and development.
  • Monitor site staff productivity, clinical trial enrollment and assignment of personnel resources to all research including new clinical trial activities.  
  • Work with the study team and CSHRI Leadership to determine best practices for clinical research operations and study budget accuracy.
  • Accountable to ensure timely data entry and tracking for both study and site information via the Clinical Trial Management System (CTMS) and other research tracking technology.
  • Recommend policies, procedures and processes that promote efficiencies and drive quality assurance.
  • Ensure research site compliance with relevant federal, state, and local regulations as well as CSHRI institutional policies and procedures.
  • Manage site staff resource allocation within budgeted targets.
  • Manage and oversee research site staff, including:
    1. Participation in staff interviews and selection processes
    2. Responsible for orientation, training, and development of research staff.
    3. Conducts initial competency assessment of research staff within 90 days of hire, transfer or promotion.
  • Provide ongoing communications (progress reports) regarding operations and site developments.
  • Contribute to projects that support the research site and CommonSpirit Research Institute organizational goals.
  • Promote a culture of individual accountability for quality assurance and improvement within the CRDM function and site research staff.  
  • Function as content expert in developing appropriate training/educational materials along with the CSHRI Research Integrity function for all site teams.  
  • Maintain high quality control standards as determined by CSHRI Senior Leadership, annual monitoring plans, and internal audit and monitoring functions.   Hold clinical site staff accountable for all internal and external research base audits and sponsor (federal and industry) monitoring visits; participates as necessary in audits and monitoring visits; review and/or prepare appropriate responses to audit reports; implement corrective actions.
  • Develop, implement and evaluate performance standards and measurements to support research coordinator and investigator compliance with protocol, GCP, FDA and other research regulatory requirements.
  • Support and promote:
    1. Standardization of division clinical research operations.
    2. Centralization of core research support services.
    3. Clinical service line based research programs including Cardiology (Interventional Cardiology, Cardiac Surgery, and Electrophysiology), Oncology, Neurology, and other specialties.
  • Seek opportunities to collaborate with other CommonSpirit Health research facilities and sites to expand research program collaborations.
  • Meet all mandatory requirements of the position including mandatory training, classes, licensure/certification, employee health requirements, and adherence to CommonSpirit Health's Code of Conduct.
  • Participate in CSHRI clinical operations oversight and strategic planning activities as directed by CSHRI senior leadership.
  • Act as liaison between all members of the CSHRI community, including facility research leadership, CommonSpirit Health administrators, physicians/ Investigators, site research personnel , CommonSpirit Health Legal, CommonSpirit Health Corporate Responsibility, and CommonSpirit Health IRB, as well as between CSHRI and industry and government sponsors of research, and government agencies including the U.S. Food and Drug Administration (FDA). (Collaboration)
  • Other duties as assigned.

~LI-DH

#missioncritical

Qualifications

  • Bachelor's degree in life sciences or a related field required. Master's degree preferred.
  • Minimum five (5) years of full-time experience in clinical trial management in a hospital, clinic or physician office setting required. Experience managing clinical trials within an integrated health system preferred.
  • Minimum three (3) years’ experience managing and supervising research staff (e.g., clinical coordinators and regulatory staff) or 5 years leadership experience in the discipline or Master’s Degree.
  • Minimum of 2 years of experience in research contract and budget development and management preferred.
  • Demonstrated knowledge of clinical trials research and related medical technology required.
  • Demonstrated knowledge of Medicare coverage analysis and research billing compliance required.
  • Demonstrated knowledge of Federal (GCP, ICH), State and other research regulatory requirements required.
  • Previous experience with Clinical Trial Management Systems (CTMS) preferred.
  • SOCRA or ACRP certification required or must meet eligibility criteria to become certified within one year of hire.

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