Clinical Research Regulatory Specialist

Baylor Scott & White Health - Plano, TX

Full-time - Mid Level

Plano, TX

Hospitals

About the position

The Clinical Research Regulatory Specialist at Baylor Scott & White Health plays a crucial role in supporting clinical research activities by developing and managing protocol-specific documents and reports. This position ensures compliance with all relevant internal, external, and federal regulations throughout the research process, from initial submission to study closure. The specialist provides regulatory guidance to clinical research programs, facilitating the submission and maintenance of necessary regulatory documents.

Responsibilities

• Prepares and coordinates the submission of Institutional Research Board (IRB) applications for protocol revisions or amendments.
• Ensures submission packets meet IRB's revision submission requirements before sending.
• Communicates and facilitates responses to queries from the IRB, Sponsor, and other committees.
• Coordinates the preparation and submission of consent forms in compliance with regulatory requirements.
• Obtains Sponsor approval of consent forms prior to IRB submission.
• Facilitates timely submission of regulatory documents and IRB submissions by collaborating with research staff.
• Maintains and audits regulatory binders.
• Tracks workload and status of pending protocols to provide efficient service to the Research team.
• Participates in quality assurance programs related to project and patient data.
• Oversees QA initiatives to assist during sponsor and FDA audits.

Requirements

• Associate's degree or 2 years of relevant work experience.
• 3 years of experience in clinical research or regulatory affairs.
• Proven written and oral communication skills.
• Proven leadership skills in project management.
• Exceptional computer skills, including proficiency in Microsoft Office, Excel, and PowerPoint.

Nice-to-haves

• Project management skills
• Ability to manage time-sensitive projects
• Excellent relationship-building skills

Benefits

• Immediate eligibility for health and welfare benefits
• 401(k) savings plan with dollar-for-dollar match up to 5%
• Tuition Reimbursement
• PTO accrual beginning Day 1