Regulatory Affairs Specialist
Summary
The Regulatory Affairs Specialist works to support the investigators and clinical research operations associated with The Texas Children's Cancer and Hematology Centers (TXCH). This position supports all aspects of regulatory compliance for a specified portfolio of over 80 studies. This support includes, but is not limited to, reviewing protocols and protocol related documents, submitting protocols to regulatory agencies and review committees and ensuring successful navigation of approval processes for clinical research. This role covers a significant portion of our Phase 1 protocols as well as protocols from our most prolific consortia (PBTC and PNOC) which require specific tasks and expertise.
A Specialist will be assigned low to mid regulatory complexity projects including large consortium protocols using a central IRB where there are less editing needs. The Specialist will handle assigned protocols independently including but not limited to sponsor correspondence, monitoring, review board submissions (initial, amendments, renewals). This role will centrally process safety reports, consortium correspondence, broadcast reviews and distirbution, team mailbox tasks, protocol approvals. The Specialist will work with their assigned PIs to maintain compliance for their assigned protocols and will cover for their peers as needed. For more complex projects, they are needing direction.
Job Duties
• Follows SOPs, coordinates regulatory correspondence across internal stakeholders and external institutions. Prepares protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of clinical research projects at the TXCH.
• Maintains and expands understanding of federal regulations, ICH GCP guidelines and internal SOPs by producing work in compliance with those regulations, guidelines and SOPs.
• Acts as a liaison between institutional review committees, regulatory agencies and the investigators to ensure that protocols obtain applicable approvals, that protocol amendments are submitted appropriately and that annual renewals are obtained.
• At the guidance of the Director, works closely with the study team, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
• Enables communication with IRB and other applicable agencies related to Adverse Events and Unanticipated Problems reporting.
• Follows SOPs, ensures distribution of appropriate information between investigators, regulatory agencies and staff involved in implementation of research projects
• Maintains regulatory database and systems as applicable (e.g. CTMS, OneDrive, Advarra eReg). Maintains electronic and paper study files in accordance with local SOPs, sponsor and general industry standards ensuring documentation is complete, up to date, and audit ready
• Keeps the study team and supervisor informed of protocol related issues.
• Practices a high level of integrity and honesty in maintaining confidentiality.
Minimum Qualifications
- High School diploma or GED.
- Four years of relevant experience.
Preferred Qualifications
- Bachelor’s degree. No experience required with Bachelor’s degree.
- Two or more years of experience in regulatory affairs and/or clinical research at academic medical center or hospital with knowledge of clinical research practices and regulations.
- Experience in regulatory affairs for clinical research preferred.
- Certification in Clinical Research, SOCRA or other preferred.
- Knowledge and understanding of clinical research compliance, including OHRP, FDA and other federal regulations and requirements regarding human subjects research, including but not limited to GCPs and related ICH guidelines, informed consent, adverse event reporting and monitoring, and other human subjects research protection requirements.
- Ability to serve as a resource to clinical investigators and staff.
- Ability to manage shifting priorities in short time frames.
Baylor College of Medicine is an Equal Opportunity/Affirmative Action/Equal Access Employer.
SN
Recommended Jobs
Salesforce Data Engineer
Salesforce Data Engineer Location San Antonio, TX (Jefferson-Monticello Park area) : Secure our Nation, Ignite your Future Become an integral part of a diverse team while working at an Industry Lead…
Remote Marketing Role - Flexible Career for Experienced Professionals
Remote-Based Marketing Role for Experienced Professionals (U.S. & Canada Only) Are you a goal-oriented professional ready to shape your next career chapter with greater flexibility and purpose? We …
Pet Care Technician
Job Description Job Description Leading pet resort in southwest Houston is looking for enthusiastic, dependable individuals to be full or part-time pet care technicians. The position includes resp…
Beauty Advisor
Sephora is seeking a Beauty Advisor in Plainview, United States, to provide personalized beauty consultations and product recommendations. The role involves staying updated on beauty trends, driving s…
Lead Medical Office Specialist
Responsibilities ABOUT SOUTH TEXAS HEALTH SYSTEM – CLINICS Join our South Texas Health System Clinics (formerly Valley Care Clinics) team! Providers with South Texas Health System (STHS) Clin…
Shift Supervisor
Job Type Full-time Description Pay: $19.50 per hour Schedule: Full-time, including evenings and weekends Key Responsibilities in this Role Include: # Lead a team of 11–15 employees t…
Clinical Pastoral Education- Educator Candidate
Interested in a career with both meaning and growth? Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland wo…
Lead Dental Assistant (EFDA)
Description Job Summary: We are seeking a skilled and compassionate Lead Expanded Functions Dental Assistant (EFDA) to join our iKids Pediatric Dentistry team. The Lead DA will be responsi…
Financial Accountant
Description The primary responsibility of the Project Accountant role is to support the finance and operating teams by maintaining accurate job costing records. This includes prepa…