Regulatory Affairs Associate - Clinical Research

Baylor College of Medicine; Houston (TX); Hybrid; USD 71.000 - 83.000; Vollzeit

Zusammenfassung

Baylor College of Medicine in Houston is seeking a Regulatory Affairs Associate for the Clinical Research Division to guide investigators through regulatory and administrative requirements for new and ongoing clinical studies.

The role collaborates with investigators, sponsors, and IRB offices; responsibilities include preparing regulatory documentation, coordinating submissions (IND/IDE), and supporting trial operations in a hybrid work setting.

Qualifikationen

• Bachelor's degree required.
• Two years of relevant experience.
• Excellent written and oral communication skills.
• Knowledge of medical/scientific terminology.

Aufgaben

• Reviews and coordinates regulatory requirements for proposed clinical research studies.
• Supports IND/IDE submissions and reporting to FDA and other agencies.
• Assists with regulatory documentation and compliance for trials.
• Serves as main contact for investigators, sponsors, IRB, and regulatory authorities.

Ausbildung

Bachelor's degree

Tools

Microsoft Office Suite

Jobbeschreibung

Regulatory Affairs Associate - Clinical Research Division: Medicine Work Arrangement: Hybrid Location: Hybrid within Greater Houston, TX Salary Range: $70,618 - $83,080 FLSA Status: Exempt Work Schedule: Monday – Friday, 8 a.m. – 5 p.m.

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.

Requisition ID: 26697

Baylor College of Medicine fosters diversity among its students, trainees, faculty, and staff as a prerequisite to accomplishing our institutional mission and setting standards for excellence in training healthcare providers and biomedical scientists, promoting scientific innovation, and providing patient-centered care. Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.