Senior Clinical Research Coordinator

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

Job summary

Tekton Research in Austin, Texas is seeking a Senior Clinical Research Coordinator to oversee multiple trials from start-up to close-out. This on-site, full-time role requires strong organization, protocol compliance, data integrity, and team mentorship.

The Senior CRC will liaise with investigators, sponsors, monitors, and staff to ensure high-quality study execution and participant safety. A clinical research background and knowledge of GCP, FDA regulations, and ICH guidelines are essential.

Qualifications

• 3–5+ years of clinical research experience with ability to independently coordinate trials.
• Strong knowledge of GCP, ICH guidelines, FDA regulations, and clinical research processes.
• Experience with pediatric and adult phlebotomy and specimen processing.

Responsibilities

• Coordinate and manage multiple clinical trials from start-up through close-out.
• Serve as primary site contact for investigators, sponsors, monitors, vendors, and study teams.
• Recruit, screen, consent, enroll, and retain study participants per protocol.
• Conduct study visits and perform pediatric and adult phlebotomy and specimen processing as required.
• Monitor participant safety and document adverse events and protocol deviations.
• Maintain regulatory documentation and source records per GCP, FDA, and ICH guidelines.
• Prepare and submit IRB and regulatory documents, amendments, and continuing reviews.
• Maintain data in EDC and CTMS; resolve data queries.
• Prepare for sponsor visits, audits, and inspections.
• Mentor junior coordinators and contribute to site quality and process improvements.

Skills

Organizational skills

Problem-solving

Communication skills

Independent work

Education

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

High school diploma or GED required

Tools

EDC systems

CTMS

Microsoft Office

Job description

Senior Clinical Research Coordinator - Austin, Texas

Full-Time/Non-Exempt/On-Site

Position Summary

The Senior Clinical Research Coordinator (Senior CRC) is an experienced clinical research professional responsible for managing multiple clinical trials from study start-up through close-out. This role ensures protocol compliance, participant safety, data integrity, regulatory compliance, and successful study execution.

The Senior CRC serves as a key liaison between investigators, sponsors, monitors, participants, and research staff while providing guidance and mentorship to junior coordinators. The ideal candidate is highly organized, proactive, detail-oriented, and able to effectively manage multiple priorities.

Key Responsibilities

• Independently coordinate and manage multiple clinical trials from start-up through close-out.
• Serve as a primary site contact for investigators, sponsors, monitors, vendors, and study teams.
• Recruit, screen, consent, enroll, and retain study participants according to protocol requirements.
• Conduct study visits and perform pediatric and adult phlebotomy and specimen processing as required.
• Monitor participant safety and appropriately document and report adverse events and protocol deviations.
• Maintain accurate source documentation, regulatory files, and essential study records in compliance with GCP, FDA regulations, and ICH guidelines.
• Prepare and submit IRB and regulatory documents, including amendments and continuing reviews.
• Maintain accurate study data in EDC and CTMS systems and resolve data queries within required timelines.
• Prepare for and support monitoring visits, sponsor audits, and regulatory inspections.
• Identify and resolve study issues proactively to maintain timelines, quality, and compliance.
• Mentor and provide guidance to Clinical Research Coordinators and other research staff.
• Contribute to process improvement and overall site quality and performance.

Required Qualifications

• High school diploma or GED required; Bachelor's degree in Nursing, Biology, Health Sciences, Public Health, Clinical Research, or related field preferred.
• 3-5+ years of clinical research experience, with 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.

Preferred Qualifications

• Current ACRP orCCRC, or equivalent certification.
• Bachelor's or advanced degree in a healthcare, public health, or clinical research field.
• 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.

Why Join Tekton Research?

At Tekton Research, you'll join a team dedicated to excellence, innovation, and improving lives through clinical research. We value professional development, collaboration, accountability, and meaningful contributions.