Clinical Research Coordinator
Trusted Medical PLLC
W2 Full-Time Clinical Research Coordinator Trusted Medical, PLLC is seeking an experienced, highly organized, and team-oriented Clinical Research Coordinator (CRC) to support our growing national clinical trials program. This position plays a key role in coordinating clinical research activities, maintaining regulatory compliance, supporting study participants, and ensuring studies remain on schedule from initiation through closeout. The ideal candidate is professional, detail-oriented, dependable, and comfortable managing multiple studies and stakeholders in a fast-paced, collaborative environment. Employment Type: Full-Time, W-2 Travel: Occasional travel may be required for national study meetings or site activities Reports To: Nurse Executive Key Responsibilities *Coordinate day-to-day operations for assigned clinical trials from study initiation through closeout. *Recruit, screen, consent, enroll, and support study participants in accordance with approved protocols. *Schedule and coordinate study visits, procedures, assessments, and follow-up appointments. *Maintain accurate source documentation, case report forms, regulatory binders, study logs, and essential study records. *Prepare and submit regulatory documentation to IRBs, sponsors, and applicable regulatory agencies. *Ensure compliance with FDA regulations, ICH-GCP guidelines, OHRP requirements, HIPAA, study protocols, and internal SOPs. *Monitor protocol adherence and proactively identify and resolve study deviations. *Track and report adverse events (AEs), serious adverse events (SAEs), enrollment goals, retention, and study milestones. *Manage investigational product inventory, storage, dispensing, accountability, and return when applicable. *Enter and verify clinical data in electronic data capture systems and resolve data queries promptly. *Coordinate specimen collection, processing, and shipment to central laboratories or biorepositories. *Serve as a primary point of contact for investigators, sponsors, CROs, study monitors, and internal teams. *Support monitoring visits, audits, quality assurance reviews, site initiation activities, and study closeout. *Assist with study budgets, invoicing, payment tracking, feasibility assessments, recruitment materials, and IRB communications. *Participate in sponsor, CRO, and consortium training meetings as required. Required Qualifications *Bachelor’s degree in Life Sciences, Healthcare, Clinical Research, or a related field. *5+ years of clinical research experience, preferably supporting multiple or national clinical studies. *Strong knowledge of FDA regulations, ICH-GCP guidelines, IRB processes, informed consent requirements, and clinical research protocols. *Experience with regulatory submissions and electronic data capture systems. *Proficiency with clinical research platforms such as REDCap, Medidata Rave, or similar systems. *Strong proficiency with Microsoft Word, Excel, PowerPoint, and related productivity tools. *Excellent written and verbal communication, organizational, and problem-solving skills. *Ability to work independently while collaborating effectively across clinical and operational teams. *Must maintain a professional, polished, and workplace-appropriate appearance and demeanor at all times when representing Trusted Medical. *Must be a strong team player who works well in a close-knit, supportive, family-oriented environment. *Must demonstrate professionalism, dependability, flexibility, respect, and a willingness to step in and support the team when needed. Preferred Qualifications *ACRP-CRC or SOCRA-CCRC certification. *Experience supporting NIH, CMS, FDA-sponsored, pharmaceutical, or federally funded research studies. *Experience supporting multi-site clinical trials. Additional Requirements Candidates must be U.S. citizens and eligible to obtain a Public Trust clearance. Trusted Medical participates in E-Verify and maintains a drug-free workplace. Why Join Trusted Medical? Join a growing clinical research organization where your expertise will directly support high-quality research, study success, and meaningful outcomes for Veterans, active-duty service members, and communities nationwide. We are looking for a candidate who not only brings strong clinical research experience, but also values professionalism, teamwork, accountability, and being part of a supportive team culture. #J-18808-Ljbffr
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