Senior Clinical Research Coordinator

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Senior Clinical Research Coordinator

Full Time Austin, TX, US

7 days ago Requisition ID: 1133

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.