Senior Clinical Research Coordinator for National Trials

Trusted Medical PLLC; Connecticut; Presencial; USD 70.000 - 100.000; Tempo integral

Resumo da vaga

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

FDA regulations

ICH-GCP

IRB processes

Informed consent

Regulatory submissions

EDC systems

REDCap

Medidata Rave

MS Office

Communication

Independent work

Formação

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

Ferramentas

REDCap

Medidata Rave

MS Office

Descrição da vaga

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.