Clinical Research Data & Regulatory Coordinator
Mary Bird Perkins Cancer Center • Baton Rouge, LA26d
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Clinical Research Data & Regulatory Coordinator
Mary Bird Perkins Cancer Center•Baton Rouge, LA
About The Position
The Data and Regulatory Coordinator collaborates with the Clinical Research team and the Principal Investigator by knowledge of current protocol requirements; maintains IRB documents, regulatory and protocol documentation for assigned clinical trials administered by the Center which may include multi-site trials; facilitates communication and correspondence between Clinical Research and sponsoring agencies; collects protocol specific information from physicians, nurses, patients, family members, local caregivers, and others utilizing protocol specific methods; ensures that all designated Clinical Research regulatory and data management activities for all clinical research sites are executed in accordance with all applicable laws, regulations, policies and protocol requirements; performs additional duties as requested by supervisor and/or described in position description.
Requirements
- Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline.
- Basic science degree, or certification or licensure in a health care field
- Demonstrated success in management of regulatory submissions activities.
Nice To Haves
- Medical or scientific research experience preferred.
- Professional Certifications preferred
Responsibilities
- Assures that the regulatory and data for trials being managed according to rules and guidelines governing the conduct of clinical research trials.
- Monitor/Auditor Preparation and Participation
- IRB Preparation and Presentation
- Protocol research document maintenance
- Policies & procedures
- Other duties and professional development
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What This Job Offers
Career Level
Mid Level
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