Senior Clinical Research Coordinator

About the Role

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.

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; 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 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.

Why Join Us

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.