Onsite Clinical Research Coordinator - Temporary

Tekton Research; Austin (TX); On-site; USD 48,000 - 64,000; Full time

Job summary

Tekton Research in Austin seeks a Clinical Research Coordinator (CRC) for a temporary on-site role. You will manage day-to-day study activities, ensure GCP and regulatory compliance, and serve as liaison among investigators, sponsors, and participants.

Requirements include a high school diploma or GED, 6–12 months of CRC experience, knowledge of GCP and FDA regulations, and proficiency with EDC/CTMS and Microsoft Office. Strong organization and communication are essential.

Qualifications

• High school diploma or GED required; Bachelor's degree in Nursing, Biology, Health Sciences, Public Health, or a related field preferred.
• Minimum of six months to one year 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 with the ability to prioritize multiple studies.
• Experience maintaining regulatory documentation and source records.
• Proficiency with EDC systems and Microsoft Office applications.
• 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 study 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 and CTMS to maintain accurate study data.
• Ensure protocol compliance while maintaining the highest standards of participant care and research integrity.

Skills

Communication skills

Organizational skills

Time management

Independent work

Multidisciplinary teamwork

Education

Bachelor's degree preferred in Nursing, Biology, Health Sciences, Public Health, or related field

Tools

EDC systems

CTMS

Microsoft Office

Job description

Tekton Research in Austin seeks a Clinical Research Coordinator (CRC) for a temporary on-site role. You will manage day-to-day study activities, ensure GCP and regulatory compliance, and serve as liaison among investigators, sponsors, and participants.

Requirements include a high school diploma or GED, 6–12 months of CRC experience, knowledge of GCP and FDA regulations, and proficiency with EDC/CTMS and Microsoft Office. Strong organization and communication are essential.