Clinical Research Coordinator

Trusted Medical PLLC; Connecticut; On-site; USD 70,000 - 100,000; Full time

Job summary

Trusted Medical, PLLC is seeking a seasoned Clinical Research Coordinator to support a national trials program. You will coordinate trials from initiation to closeout, recruit and enroll participants, manage regulatory documentation, and ensure FDA/ICH-GCP compliance.

The role requires strong organizational skills, attention to detail, and the ability to collaborate across investigators, sponsors, and internal teams. This is a full-time, W-2 position based in the United States.

Qualifications

• Bachelor’s degree in Life Sciences, Healthcare, Clinical Research, or related field.
• 5+ years of clinical research experience, preferably multi-site or national studies.
• Strong knowledge of FDA regulations, ICH-GCP, IRB processes, and informed consent.

Responsibilities

• Coordinate day-to-day operations for assigned clinical trials from initiation to closeout.
• Recruit, screen, consent, enroll, and support study participants per protocols.
• Schedule visits, procedures, assessments, and follow-ups.
• Maintain source docs, CRFs, regulatory binders, and study records.
• Submit regulatory documents to IRBs, sponsors, and agencies.
• Ensure compliance with FDA, ICH-GCP, HIPAA, and SOPs.
• Monitor protocol adherence and address deviations.
• Track AEs/SAEs, enrollment goals, retention, and milestones.
• Manage investigational product inventory and accountability.
• Enter and verify data in EDC systems and resolve queries.
• Coordinate specimen collection and shipping to labs or biorepositories.
• Serve as primary contact for investigators, sponsors, CROs, monitors.
• Support monitoring visits, audits, and training meetings.
• Assist with study budgets, invoicing, and feasibility assessments.

Skills

FDA regulations

ICH-GCP

IRB processes

Informed consent

Regulatory submissions

EDC systems

REDCap

Medidata Rave

MS Office

Communication

Independent work

Education

Bachelor's degree in Life Sciences/Healthcare/Clinical Research

Tools

REDCap

Medidata Rave

MS Office

Job description

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.