Posted: 29-Mar-25
Location: Dallas, Texas
Internal Number: 25003844
JOB SUMMARY
The Clinical Research Supervisor provides day-to-day supervision tot he Clinical Research Regulatory Affairs department. This position develops, negotiates and monitors budgets related to funded research projects, facilitates the implementation of clinical research projects, and monitors for quality and timely completion.
LOCATION
The work location for this position is in-person between our Dallas campus and The Heart Hospital - Plano (dependent on business needs)
ESSENTIAL FUNCTIONS OF THE ROLE
- Writes and assists in the development of proposals, grants, contracts and budgets for the department.
- Assists in the development of new protocols and other materials provided by study sponsors and provides input to Principal Investigators (PI) and management regarding clinical and research issues in order to establish financial and clinical feasibility.
- Assists various PIs, through delegated authority, in conducting clinical trials per federal, state and institutional guidelines.
- Prepares initial submission of projects, notification of amendments, Serious Adverse Event (SAE) reports, continuing review reports and other reports submitted to the Institutional Review Board (IRB). Reviews submissions prepared by staff to ensure that all submissions meet established standards.
- Oversees case report form completion performed by staff for all studies and assists in the coordination of audits by the study sponsor monitors. Monitors assigned Clinical Research funds.
- Orientates, trains, supervises and evaluates Clinical Research staff. Encourages continuing growth through more complex responsibilities and formal education programs. Coordinates project assignments for staff.
- Establishes and maintains good relations with the public, patients and staff; promotes department's research programs.
- Monitors communication with the IRB, Food and Drug Administration (FDA) and other applicable regulatory agencies.
KEY SUCCESS FACTORS
- Research certification or other certifications per specialty area preferred.
- Basic Life Support (BLS) per department requirements.
- Proven written and oral communication skills.
- Proven computer skills, including Microsoft office, Excel and PowerPoint.
- Ability to manage time impressible projects in order to meet deadlines.
- Ability to establish and maintain effective working relationships.
- Excellent leadership skills.
- Previous regulatory affairs experience is highly preferred. Previous supervisory experience is a plus but not required.
- Proficient in medical terminology and federal policies & regulations pertinent to research involving human subjects preferred.
BENEFITS
Our benefits are designed to help you live well no matter where you are on your journey. For full details on coverage and eligibility, visit the Baylor Scott & White Benefits Hub to explore our offerings, which may include:
- 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
Note: Benefits may vary based upon position type and/or level
QUALIFICATIONS- EDUCATION - Bachelor's or 4 years of work experience above the minimum qualification
- EXPERIENCE - 2 Years of Experience