Southern Illinois Healthcare · 1 day ago
Manager, Clinical Research
Carbondale, IL
Full-time
Onsite
Mid Level
$89K/yr - $140K/yr
3+ years expSouthern Illinois Healthcare is seeking a Manager for Clinical Research to oversee a portfolio of clinical studies aimed at measuring the efficacy of medical products or protocols. The role involves managing the Institutional Review Board and ensuring compliance with federal regulations while assisting with the analysis of clinical research data.
Health CareHealth DiagnosticsHospitalOncologyPersonal Health
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 affiliates and organizations in research/study/grant efforts. Including but not limited to; SIU – School of Medicine, Prairie Heart Institute, Decatur Memorial Hospital, American Heart Association, etc
Qualification
Required
Bachelors Degree in Health Care Management, Research, Accounting, or Nursing
CIP (PRIM&R) after two years IRB 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
Preferred
Master's Degree Preferred
Company
Southern Illinois Healthcare
Southern Illinois Healthcare offers cancer care, plastic surgery, and rehabilitation services.
1001-5000 employees
H1B Sponsorship
Southern Illinois Healthcare has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (9)
2023 (7)
2022 (2)
2021 (11)
2020 (8)
Funding
Current Stage
Late StageLeadership Team
Bart Millstead
Senior Vice President/Chief Operating Officer
Denao Ruttino, CHCIO, CDH-E, FACHE
Vice President and Chief Innovation Officer
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