About this role
Summary The Department of Medicine is seeking an enthusiastic Regulatory Affairs Associate to join the Departmental Clinical Trials Administration Unit who will guide and support investigators in starting a new clinical trial study and existing studies. Will be responsible for reviewing and coordinating the regulatory and administrative requirements for conducting proposed research; guiding in the accumulation of regulatory documentation, supporting daily activity such as recruiting study subject, data entry to investigators when requested. Will work alongside other members of the clinical trial administration unit and department research administration team to ensure a successful trial is established.
- Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.
- Job Duties Works with financial analyst, PI to assess budgetary needs on clinical trial studies (protocol reviews).
- Manages clinical study regulatory work for research studies or clinical trials.
- Assists with regulatory affairs training and research system training.
- Assists with IND/IDE submission and reporting to the FDA and other government agencies and serve as subject expert on all regulations related to clinical research.
- Prepares and submits protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of clinical research projects (BRAIN, CTA and Sponsors).
- Communicates with both external and internal stakeholders such as IRBs and PIs related to submissions, renewals, and adverse events.
- Serves as main contact for investigators, sponsors, government agencies, and the IRB office.
- Supports daily operations for a research study or clinical trial.
- Performs other job-related duties as assigned.
Minimum Qualifications
- Bachelor's degree.
- Two years of relevant experience.
Preferred Qualifications
- Certifiend IRB professional (CIP) or Regulatory Affairs Certification (RAC) preferred.
- Should have excellent oral and written communication skills.
- Knowledge of medical/scientific terminology.
- Excellent organization skills; ability to multi-task.
- Strong computer skills including Microsoft Office Suite.
- High sense of professional behavior and conduct and an ability to communicate with various levels of faculty and staff within Baylor College of Medicine and outside organization.
- Work Authorization Requirement: This position is not eligible for visa sponsorship.
- Candidates must be legally authorized to work in the United States at the time of application and throughout the duration of employment.
- Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.