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About the Role

The Senior Clinical Research Coordinator (Senior CRC) is an experienced professional responsible for managing multiple clinical trials from study start-up through close-out, ensuring protocol compliance, participant safety, data integrity, regulatory compliance, and successful study execution. This role serves as a key liaison between investigators, sponsors, monitors, participants, and research staff, while also providing guidance and mentorship to junior coordinators.

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.

Requirements

High school diploma or GED required.
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.

Skills

GCP
ICH guidelines
FDA regulations
EDC systems
CTMS
Microsoft Office
Organizational skills
Problem-solving skills
Communication skills
Phlebotomy
Specimen processing

Location

Austin, Texas

Work Type

Full-Time
On-Site

Experience Level

Senior

Education Level

High school diploma or GED
Bachelor's degree in Nursing, Biology, Health Sciences, Public Health, Clinical Research, or related field preferred
Bachelor's or advanced degree in a healthcare, public health, or clinical research field (preferred)
Current ACRP or CCRC, or equivalent certification (preferred)

About the Company

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.
If you're an experienced clinical research professional ready to take on greater responsibility and help lead high-quality clinical trial execution, we encourage you to apply and become part of the Tekton Research team.