Manager-Research Program Heart and Vascular

Job Description:

Under the general supervision of the Service Line Leadership and specialty Medical Director, directs the operational functions, leads, and manages all aspects of research. Takes an active role in leading the program related to research throughout all appropriate WellSpan research sites in conjunction with physician leaders.

Duties and Responsibilities

1. Collaborates with the Medical Director, Chief Medical Officer and the Service Line Leadership to promote the development of research strategies as well as promoting WellSpan wide representation for their specialty.
2. Oversees the day-to-day duties of the personnel ensuring safety and integrity of research processes, as well as ensuring regulatory compliance.
3. Assist in creating operating budgets for the research cost center with designated research accounts.
4. Conducts the internal feasibility process and provides recommendations related to feasibility of opening new projects and a process of closing projects that fail or finish meeting projected outcomes.
5. Monitors staffing levels and identifies adequate coverage for trial workload across the study coordinators and team.
6. Oversees the hiring, orientation, education, and training of the research team.
7. Supervises the implementation of and adherence to study protocols. Educates research staff on established policies, processes, and procedures.
8. Oversees the coordination of new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies.
9. Audits operations, including laboratory procedures, to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes.
10. Oversees financial resources, as needed, creates internal and external budgets for research protocols as needed, assures financial accountability, and serves as primary liaison between sponsors, department accounting and WellSpan Research Business Office.
11. Prepares reports on study progress, quarterly or as needed by service line administration, principal investigators and/or external agencies. Responds to special needs or queries related to research projects/programs.
12. Oversight of performance/productivity measures for assigned research program(s). Provides regular updates to Service Line Leadership and principal investigators.
13. Establishes a mechanism to measure physician satisfaction within the assigned service line(s). Implements action plans to address identified issues, as necessary.
14. Engages and manages the performance of the team and ensure that Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), Health Insurance Portability and Accountability Act (HIPAA), regulatory guidelines, and all best practices are followed rigorously. This includes development and preparation of Clinical Protocols, ensuring that Investigator's Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), and Clinical Study Reports (CSRs) are completed and followed.
15. Ensures compliance with expectations of external review organizations, most notably the Food and Drug Administration (FDA), Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP), Institutional Review Board (IRB), and the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP).
16. Creates a cohesive work team that works collaboratively to achieve the research goals of the system.

Qualifications

• Notes:
  • Other combinations of formal education, training and experience may be considered.

• Minimum Experience:
  • Minimum of 3-5 years of experience in clinical research/clinical trials management; 5 years’ experience in leadership/management with demonstrated leadership skills.

• Min Field of Expertise: Clinical Research Regulations, Regulatory Compliance, Management Skills, Medical Terminology

• Required Certification: National certification related to clinical research (CCRC or CCRP) or IRB administration or be willing to obtain the certifications within the first year.

• Minimum Education:
  • Bachelor's Degree in a biological science or health related field is required

• Preferred Certification:
  • CCRP or CCRC through a professional organization

• Skills:
  • Advanced computer skills; excellent planning and organizing skills; Problem-solving skills; Strong administrative skills; excellent interpersonal/ communication skills; excellent written and oral communication skills; ability to follow multiple, detailed directions of various research protocols; ability to work independently and to interpret related federal regulations; excellent computer skills including proficient in Microsoft Office applications. Adaptable to new software programs. Experience with IRB management systems.
  • Training/experience in the responsible conduct of research, including medical/research ethics and protection of the safety and welfare of human subjects in research. Experience in providing technical instructions to others. Experience in the conduct of Sponsored and Investigator Initiated research.