Senior Clinical Research Lead - Trials & Compliance

Tekton Research Inc; Austin (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Tekton Research Inc. in Austin, TX is seeking a Senior Clinical Research Coordinator to oversee multiple trials from start-up to close-out.

You will ensure protocol compliance, participant safety, data integrity, and regulatory adherence while serving as a key liaison among investigators, sponsors, monitors, and research staff. The ideal candidate has 3–5+ years of clinical research experience, strong knowledge of GCP/ICH, and the ability to mentor junior coordinators.

Qualifications

• 3–5+ years of clinical research experience with independent trial coordination.
• Strong knowledge of GCP, ICH guidelines, and FDA regulations.
• Experience coordinating multiple trials and prioritizing competing tasks.

Responsibilities

• Coordinate multiple clinical trials from start-up through close-out.
• Serve as primary site contact for investigators, sponsors, monitors, and study teams.
• Recruit, screen, consent, enroll, and retain participants per protocol.
• Conduct study visits and pediatric/adult phlebotomy and specimen processing as required.
• Monitor participant safety and document adverse events and deviations.
• Maintain regulatory files, source documentation, and essential study records per GCP/ICH.
• Prepare IRB and regulatory documents, amendments, continuing reviews.
• Maintain data in EDC and CTMS and resolve data queries on timelines.
• Prepare for sponsor visits, audits, and inspections.
• Mentor and guide CRCs and staff.
• Contribute to process improvement and site quality.

Skills

Clinical research

GCP/ICH knowledge

Multi-tasking & priorities

Communication skills

Education

Bachelor's degree in Nursing or related field

Tools

EDC systems

CTMS

Microsoft Office

Job description

Tekton Research Inc. in Austin, TX is seeking a Senior Clinical Research Coordinator to oversee multiple trials from start-up to close-out.

You will ensure protocol compliance, participant safety, data integrity, and regulatory adherence while serving as a key liaison among investigators, sponsors, monitors, and research staff. The ideal candidate has 3–5+ years of clinical research experience, strong knowledge of GCP/ICH, and the ability to mentor junior coordinators.