ResponsibilitiesPurpose of Position and Scope of Responsibility:
Regulatory Affairs of the Baptist Memorial Health Care System clinical research departments .Works closely with Executive Director on creating and maintaining SOPs for the regulatory department and provides standard reports on various functions.
Ensure education and compliance of human subject's protections training (CITI) and Good Clinical Practice (GCP) for investigators and staff in accordance with FDA Regulations and Standard Operating Procedures (SOP).Provide notification of renewal requirements for required training.
Establish mechanisms across research teams to ensure that regulatory submissions are high quality and filed in a timely manner to meet business objectives.Ensure compliance with local and national IRB requirements and SOPs.
Responsible for demonstrating professional demeanor and maintaining confidentiality in all interactions with both internal and external contacts.
Multi-Center Operations of the clinical research departments of the Baptist Memorial Health Care system.Provide effective and efficient management of the regulatory operations for clinical trials performed at multiple clinical sites and participating clinics of the Baptist Clinical Research Institute.Oversight includes day to day management and supervision of BCRI regulatory staff that execute and manage study conduct, protocol and regulatory compliance. Perform ongoing monitoring and evaluation of clinical trials to assure compliance with federal and institutional regulations.
Cooperative Group Operations.Oversight of all cooperative group activities related to the regulatory process.Ensure clinical investigators are up to date with annual registration requirements.Complete initial and ongoing agreements between BMHCC and the National Cancer Institute IRB to provide Institutional Review Board services for Cooperative Group trials.Complete annual registration for the Baptist Cancer Centersand each principal investigator participating in Cooperative Group trials.
Investigator-Initiated Trials:Provide regulatory guidance and assistance to Investigators in filing applications and/or exemptions to the FDA and the IRB for Investigator-Initiated Clinical Trials. Requirements, Preferences and Experience About Baptist Memorial Health Care
At Baptist, we owe our success to our colleagues, who have both technical expertise and a compassionate attitude. Every day they carry out Christ's three-fold ministry-healing, preaching and teaching. And, we reward their efforts with compensation and benefits packages that are highly competitive in the Mid-South health care community. For two consecutive years, Baptist has won a Best in Benefits award for offering the best benefit plans compared with their peer groups. Winners are chosen based on plan designs, premiums and the results of a Benefits Benchmarking Survey.At Baptist, We Offer:
- Competitive salaries
- Paid vacation/time off
- Continuing education opportunities
- Generous retirement plan
- Health insurance, including dental and vision
- Sick leave
- Service awards
- Free parking
- Short-term disability
- Life insurance
- Health care and dependent care spending accounts
- Education assistance/continuing education
- Employee referral program
Position: 11953 - Manager-Regulatory
Facility: BMHCC Corporate Office
Department: BCRI Baptist Clinical Research
Category: Leadership & Administration
Type: Non Clinical
Work Type: Full Time
Work Schedule: Days
Located in the Memphis metro area