Senior Clinical Research Coordinator

Tekton Research Inc•Austin, TX

12h•Onsite

About The Position

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.

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.

Nice To Haves

Bachelor's degree in Nursing, Biology, Health Sciences, Public Health, Clinical Research, or related field preferred.
Current ACRP or CCRC, 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.

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.