Regulatory Affairs Associate



Summary

This position is responsible for regulatory oversight and operations of an exciting investigator initiated, industry sponsored, 2 center randomized controlled clinical trial. The clinical trial will test the efficacy of an immunomodulator in hospital inpatients with COVID-19. The Regulatory Affairs Associate will lead a team of investigators, site managers, personnel and statisticians to complete this trial with the sponsor (Baylor College of Medicine) and a second site (Brigham Woman's). They will demonstrate a knowledge of regulatory affairs for clinical research at an academic medical center or hospital and have broad knowledge of the IRB and FDA process.

Job Duties
  • Lead a team of investigators, site managers, personnel and statisticians to complete the trial with the sponsor and second site. This includes planning the studies and ensuring appropriate training of the lab staff in the technical, analytical, and scientific aspects of the project.
  • Responsible for regulatory oversight and compliance of the project to include drafting reports to the FDA and other regulatory bodies.
  • Communicates with the IRB related to submissions, renewals, and adverse events.
  • Act as a liaison between Baylor and Brigham Women’s and handle all components of multiple site coordination.
  • Responsible for operational oversight of the project to include creating and monitoring timelines and keeping the project compliant and on track.
  • Prepare abstracts and manuscripts to contribute scientific and clinical results.
  • May coordinate travel requests and reimbursements for research residents within the College.
  • May coordinate procurement of equipment and supplies as needed.
  • May assist with research coordination as needed.


Minimum Qualifications
  • Education Required: Bachelor's degree.
  • Experience Required: Two years of relevant experience.
  • Certification/Licenses/Registration: None Required.


Preferred Qualifications
  • Experience with multi-site coordination and management
  • Demonstrated knowledge of regulatory processes and applicable regulations.
  • Ability to manage regulatory aspects of multiple research projects.


Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.

4644

CA; CH

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