On-Site Clinical Research Coordinator (Temp)

Tekton Research Inc; Austin (TX); On-site; USD 50,000 - 70,000; Full time

Job summary

Tekton Research Inc. is seeking a Temporary Clinical Research Coordinator to manage day-to-day trial coordination on-site in Austin, TX.

The CRC will liaise between investigators, sponsors, participants, and regulators to ensure safety, data integrity, and trial success. The role requires strong organizational skills, attention to detail, and the ability to manage multiple trials concurrently in a fast-paced environment.

Qualifications

• High school diploma or GED required; Bachelor’s degree preferred.
• 6–12 months of Clinical Research Coordinator experience.
• Working knowledge of GCP, FDA regulations, ICH guidelines, and clinical research processes.
• Experience with pediatric and adult phlebotomy and specimen processing.
• Strong organizational and time management skills.
• Proficiency with EDC systems and Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work independently while collaborating effectively with multidisciplinary teams.

Responsibilities

• Coordinate and manage all aspects of assigned clinical trials from start-up through close-out.
• Recruit, screen, consent, and schedule study participants according to protocol requirements.
• Collect, process, package, and ship laboratory specimens according to protocol and sponsor requirements.
• Maintain accurate source documentation, regulatory binders, and study records in compliance with GCP, FDA regulations, and institutional policies.
• Monitor participant safety and promptly identify, document, and report adverse events.
• Prepare and submit regulatory documents, including IRB submissions, continuing reviews, and protocol amendments.
• Collaborate with investigators, sponsors, monitors, and study staff to ensure successful study conduct.
• Assist with monitoring visits, sponsor audits, and regulatory inspections.
• Utilize EDC systems and CTMS to maintain accurate study data.
• Ensure protocol compliance while maintaining the highest standards of participant care and research integrity.

Skills

GCP knowledge

FDA regulations

ICH guidelines

Regulatory documentation

EDC systems

CTMS

Communication skills

Team collaboration

Education

Bachelor's degree preferred

Tools

EDC systems

Microsoft Office

CTMS

Job description

Tekton Research Inc. is seeking a Temporary Clinical Research Coordinator to manage day-to-day trial coordination on-site in Austin, TX.

The CRC will liaise between investigators, sponsors, participants, and regulators to ensure safety, data integrity, and trial success. The role requires strong organizational skills, attention to detail, and the ability to manage multiple trials concurrently in a fast-paced environment.