Manager, Clinical Research

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Position Summary
• Responsible for the design and administration of a portfolio of clinical research studies that are meant to measure the efficacy of products or protocols that are expected to serve a medical need; Overseeing all research activities; including but not limited to the management of the Institutional Review Board (IRB), cross the Southern Illinois Healthcare System (SIH) as well as Southern Illinois Medical Services (SIMS); Review research specifications and assigns resources; Ensure all related activities are performed in accordance with Federal regulations, SIHS, and sponsoring agencies policies and procedures; and Assists with the analysis and interpretation of clinical research data.

Education
• Bachelors Degree in Health Care Management, Research, Accounting, or Nursing.
• Master’s Degree Preferred

Licenses and Certification
• CIP (PRIM&R) after two years IRB experience

Experience and Skills
• Experience: 3 years of demonstrated organization and process skills within a health care organization conducting research, financial management, conflicts of interest, compliance, Human Research Participation Protection, Protocol Preparation & Review.

Role Specific Responsibilities
• Manages the IRB, policies, procedures, records, education, training and FWA and its members in accordance with Federal regulations.
• Assists Principal Investigators and student applicants with the application submission process. Interprets and advises investigators on applicable policies, procedures, guidelines, federal regulations, and other compliance related requirements. Answers various questions and may guide investigators through some processes.
• Screens research study applications to determine completeness and accuracy. Determines if studies meet review criteria for exempt, expedited, or full board by reviewing the IRB application, protocol and consent forms, ensuring they receive appropriate review according to federal regulations.
• Screens revised applications and resubmissions, reviews changes, and if acceptable, forwards to IRB Chairperson for final review.
• Assigns exempt and expedited studies to IRB Chairperson for review. Coordinates with principal investigators for preparation of material for board meetings. Generates correspondence on behalf of IRB Chairpersons and Chief Medical Officer. Stamps study documents appropriately. Distributes correspondence to Investigators.
• Act as a liaison between the IRB, the IRB Chairperson, and Investigators. Responsible for following up with investigators to ensure they are aware of the time limits and deadlines. Coordinates and schedules monthly reviews and annual reports with the IRB.
• Coordinates meetings for the Institutional Review Boards. Creates agenda, and ensures there is an appropriate composition of members to make quorum according to federal regulations. Ensures proper procedures are followed. Creates board letters with instructions for corrections based on deliberations at the meeting. Takes minutes, prepares written draft, and distributes to the IRB Chairperson as required.
• Promotes ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within SIHS policy.
• Assists PI with scientific and compliance reporting requirements in accordance with Federal regulations, SIHS, and sponsoring agency policies procedures.
• Reviews and accepts/corrects the billing matrix as set up by the Center for Applied Research Science (CARS) to facilitate billing of study procedures to appropriate research fund.
• Oversees the clinical monitoring process and the administration of clinical trials by supervising in-house Clinical Trial Research Specialists and conducting on-site monitoring, filing, and clinical trial administration.
• Oversee all adherence to organizational SOPs, Good Clinical Practice (GCP), and FDA regulations.
• Helps with the development and implementation of clinical processes, procedures, and programs.
• Manages Clinical Trial Research Specialists in the day-to-day performance of their jobs. Ensures that project/department milestones/goals are met and adhering to approved budgets.
• Coordinates appropriate and timely payments to participants (if applicable) in accordance with SIHS policies and procedures.
• Assists PI in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations, SIHS, and sponsoring agency policies and procedures.
• Avoids conflicts of interest, or the appearance of conflicts between financial or other personal interests and goals and policies of SIHS
• Networks with outside affiliate