Location: New Orleans, LA
The Regulatory Manager is a full-time staff member who participates in the development, implementation and regulatory compliance maintenance of clinical research trials for multiple sites and studies of different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating Procedures (SOP'S), and study specific protocols/plans and processes. The Regulatory Manager will be required to complete Good Clinical Practices (GCP) training, and additional specialized regulatory training, sponsor training on protocol requirements, etc. The Regulatory Manager will manage, directs, plan and schedule activities and programs for the regulatory department.Required Knowledge, Skills, and Abilities:
- Excellent written and oral communication skills
- Knowledge of good clinical research practice
- In-depth knowledge of IRB submission process and requirements
- Ability to acquire and maintain all required CITI training certificates
- Ability to supervise team
- Bachelor's degree or RN with current Louisiana state licensure at the time of hire and five (5) years of related work experience, including three (3) years of direct regulatory experience;
- A Master's degree and three (3) years of related work experience
- Certification as a Certified Clinical Research Coordinator (CCRC through the Association of Clinical Research Professionals or ACRP) OR Certified Clinical Research Professional (CCRP through the Society of Clinical Research Associates or SoCRA) is preferred.
This position is assigned to pay grade P4.27. Tulane offers a variety of options to enhance your health and well-being so that you may enjoy more out of life now and in the future. Learn more about Life at Tulane
as well as our Benefits and Pay. See our Candidate Resources to learn more about our hiring process and what to expect.
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This position will close on the date it is filled
Tulane University is an EOE/M/F/Vet/Disabled employer with a strong commitment to diversity and inclusion. Applications by members of all underrepresented groups are encouraged.