Senior Clinical Research Coordinator
On-siteAustin, Texas, United States
Job Summary
Independently coordinate and manage multiple clinical trials from start-up through close-out, serving as the primary site contact for investigators, sponsors, monitors, and vendors. Recruit, screen, consent, enroll, and retain study participants while conducting visits and performing pediatric and adult phlebotomy and specimen processing. Monitor participant safety, document adverse events, and maintain accurate source documentation and regulatory files in compliance with GCP, FDA, and ICH guidelines. Prepare IRB and regulatory documents, manage EDC and CTMS data, and support monitoring visits and audits. Mentor junior coordinators and proactively resolve study issues to ensure quality and compliance. Join a team dedicated to excellence and improving lives through clinical research.
Required Qualifications
- High school diploma or GED required
- Bachelor's degree in Nursing, Biology, Health Sciences, Public Health, Clinical Research, or related field
- 3-5+ years of clinical research experience
- demonstrated ability to independently coordinate clinical trials
- Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical research processes
- Experience managing multiple clinical trials and competing priorities
- Experience with pediatric and adult phlebotomy and specimen processing
- Experience maintaining regulatory documentation and source records
- Proficiency with EDC systems, CTMS, and Microsoft Office
- Strong organizational, problem-solving, and communication skills
- Ability to work independently, exercise sound judgment, and collaborate effectively with multidisciplinary teams
- Commitment to participant safety, data integrity, and research quality
Desired Qualifications
- Bachelor's or advanced degree in a healthcare, public health, or clinical research field
- Current ACRP or CCRC, or equivalent certification
- Experience with industry-sponsored and/or multi-center clinical trials
- Experience mentoring junior research staff
- Experience supporting sponsor audits, regulatory inspections, or complex monitoring activities
- Experience with participant recruitment and retention strategies
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