Senior Regulatory Affairs Associate

Senior Regulatory Affairs Associate

The Dan L. Duncan Comprehensive Cancer Center (DLDCCC) has an immediate opening for a Senior Regulatory Affairs Associate. The Senior Regulatory Affairs Associate, as a member of the Clinical Trials Support Unit of the DLDCCC, works to provide regulatory compliance and study start-up support to physician investigators in one or more designated oncology disease areas. This support includes, but is not limited to preparing clinical trial submissions for review by internal and external regulatory agencies and oversight bodies, shepherding trials through the local approval process and providing guidance from a seasoned regulatory perspective to investigators and study staff. Employees with Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification are eligible for certification pay.

Job Duties:

• Prepare all initial, amendment and continuing review submissions for assigned clinical trials, ensuring adherence with internal timelines and any external deadlines (e.g. approval expiration dates) through the use of various online research interface portals.
• Attend assigned Disease Working Group meetings and provide feedback to investigators regarding the status of trials in the queue.
• Create and maintain the site regulatory files for assigned clinical trials by entering the necessary approvals and metrics into the Clinical Trials Management System and following the internal best practices and timelines for electronic filing of essential regulatory documents as well as compliant maintenance of physical documents.
• Act as a subject matter expert with regard to regulatory compliance and be able to apply knowledge of current research regulations (FDA, ICH/GCP, local affiliate rules) to commonly encountered situations in the conduct of clinical research in an academic setting.
• Provide training, on-boarding and mentoring to newly hired or junior Regulatory Affairs Associates with regard to general regulatory knowledge, departmental processes and expectations.
• Assist in the creation of internal guidances, tools, and checklists to support greater efficiency in departmental workflows.
• Perform other job-related duties as assigned.

Minimum Qualifications:

• Bachelor's degree.
• Four years of relevant experience.

Preferred Qualifications:

• Four years of experience in clinical research regulatory affairs.
• Knowledge and familiarity with clinical research compliance and regulations, including FDA, OHRP and ICH/GCP.
• Must have excellent oral and written communication skills, ability to multi-task and high attention to detail.
• Must be able to work independently and as part of a team unit and possess the interpersonal skills necessary to work productively with a variety of internal and external stakeholders, such as industry sponsors/their representatives, clinicians, staff and co-workers within the department.

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.