Regulatory Affairs Associate

Summary

The Dan L. Duncan Comprehensive Cancer Center (DLDCCC) has an immediate opening for a Regulatory Affairs Associate. The 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 regulatory perspective to investigators and study staff.

This position will support a busy, diverse and rapidly growing group of research investigators in the Gastrointestinal Oncology Disease Working Group and will have a direct and significant impact on the clinical research operational structure of the Cancer Center and thus, contribute to the overall research mission of the College. The ideal candidate would be able to integrate with the team and offer immediate support (after an appropriate training/oversight period) to keep operations running smoothly; however, candidates with minimal experience that are eager to train and learn will be considered for the position. The Regulatory Affairs Associate will be entrusted with proprietary research information, such as clinical trial protocols, drug brochures and research data. As such, it is important that the individual be appreciative of the confidential nature of many of the tasks and duties assigned to them. This position offers the possibility of a hybrid work arrangement (a mix of in-office and remote working accommodations) after the candidate has been appropriately trained.

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.
• 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.
• Must be able to manage multiple competing priorities of deadlines and projects while maintaining a high quality work product in the context of opening oncology clinical trials within an NCI-designated comprehensive cancer center housed within the BCM academic medical center matrix.
• Must be able to coordinate and align the needs of multiple stakeholders while shepherding a study through local approval procedures. This requires a thorough understanding of the approval process, best practices for structuring and timing submissions so as to obtain approval within a reasonable time frame. Opening clinical trials in a timely manner allows investigators maximum opportunity to accrue clinical trial subjects, which is a key metric in maintaining the prestigious and coveted comprehensive status of the Dan L. Duncan Cancer Center.

Minimum Qualifications

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

Preferred Qualifications

• Certification as a Research Professional (SOCRA or ACRP certified)
• 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

Baylor College of Medicine requires employees to be fully vaccinated -subject to approved exemptions-against vaccine-preventable diseases including, but not limited to, COVID-19 and influenza.

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

11593

CA; CH