Position Summary We are seeking a Clinical Research Coordinator (CRC) to join our growing research team. The CRC plays a pivotal role in the management and execution of sponsor-funded clinical trials. This position oversees all aspects of assigned studies from study start-up through closeout while ensuring compliance with Good Clinical Practice (GCP), FDA regulations, ICH guidelines, IRB requirements, sponsor protocols, and Key Clinical Research Standard Operating Procedures (SOPs). The CRC serves as the primary point of contact for study participants, sponsors, Contract Research Organizations (CROs), monitors, and internal staff. This role requires exceptional organizational skills, attention to detail, critical thinking, and the ability to manage multiple studies while maintaining participant safety and data integrity. Clinical Trial Coordination Coordinate and manage assigned clinical trials from site initiation through study closeout. Maintain study timelines and ensure protocol milestones are achieved. Ensure compliance with sponsor protocols, GCP, FDA regulations, ICH guidelines, HIPAA, IRB requirements, and internal SOPs. Coordinate study start-up activities including training, regulatory documentation, and study supplies. Prepare studies for closeout and archive essential documents. Participant Management Recruit, prescreen, screen, consent, enroll, and retain study participants. Schedule and coordinate participant visits. Educate participants and caregivers regarding study procedures. Monitor participant safety throughout study participation. Identify and document adverse events, serious adverse events, and protocol deviations. Maintain communication to promote participant retention. Study Documentation & Data Management Maintain complete and accurate source documentation. Complete electronic Case Report Forms (eCRFs). Resolve data queries promptly. Maintain investigator site files and essential regulatory documentation. Ensure documentation follows ALCOA+ principles. Maintain inspection-ready records. Sponsor & Monitor Communication Serve as the primary liaison between sponsors, CROs, monitors, vendors, and internal staff. Coordinate site initiation, monitoring, remote monitoring, and closeout visits. Respond to sponsor requests promptly. Coordinate laboratory, imaging, ECG, and specialty vendors. Participate in investigator meetings and sponsor training. Regulatory & Quality Maintain compliance with

ICH-GCP, FDA

regulations, HIPAA, IRB requirements, sponsor protocols, and KCR SOPs. Assist with FDA inspections, sponsor audits, and quality improvement initiatives. Laboratory & Clinical Procedures Collect, process, package, and ship laboratory specimens. Perform phlebotomy when qualified. Maintain laboratory equipment and temperature logs. Coordinate imaging and specialty procedures. Assist physicians during study visits as needed. Qualifications Bachelor's degree in Nursing, Psychology, Biological Sciences, Healthcare Administration, Public Health, or a related field. Minimum two years of clinical research experience preferred. Working knowledge of

GCP, FDA

regulations, and clinical trial conduct. Strong understanding of medical terminology. Excellent organizational and communication skills. Ability to prioritize multiple studies. Experience with Microsoft Office and EDC systems. CCRC certification preferred. Phlebotomy certification or experience preferred. Experience coordinating sponsor-funded Alzheimer's disease or neuropsychiatric trials is a plus. Core Competencies Organization Time Management Attention to Detail Problem Solving Professional Communication Regulatory Compliance Participant Advocacy Team Collaboration Critical Thinking Adaptability Accountability Professional Development Sponsor-required protocol training Good Clinical Practice (GCP) certification Continuing education opportunities Investigator meetings Industry conferences CCRC certification support Leadership development opportunities Physical Requirements Ability to stand, sit, and walk for prolonged periods. Ability to lift up to 25 pounds. Manual dexterity required for computer documentation. Why Join Key Clinical Research? At Key Clinical Research, we are committed to advancing medicine through high-quality clinical research while providing exceptional care to every participant. We foster a collaborative environment focused on innovation, integrity, and professional growth.

Job Type:

Full-time Pay:

$21.00 - $24.00 per hour

Benefits:

401(k) Paid time off Professional development assistance Referral program

Work Location:

In person