Clinical Research Coordinator (Clinical Trials)
(Phase I/II | Patient-Facing | Regulatory & Data Focused)
Full-Time | 30 40 hours per week
LocationOnsite Bethesda, MD (No remote option)
Role OverviewWe are seeking an experienced Clinical Research Coordinator (CRC) to support the planning, execution, and management of clinical trials , including early-phase and first-in-human studies. This role will work closely with investigators, clinical staff, and research participants to ensure studies are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and approved protocols.
The ideal candidate will have strong patient-facing experience , hands-on involvement in clinical trial coordination , and a solid understanding of regulatory documentation, data integrity, and trial operations .
Key Responsibilities Clinical Trial CoordinationCoordinate daily activities for assigned clinical research studies
Support initiation, conduct, monitoring, and close-out of clinical trials
Assist with protocol development, review, revisions, and implementation
Ensure study activities follow approved protocols, SOPs, and regulatory standards
Screen, recruit, and schedule research participants
Obtain and document informed consent/assent in accordance with regulations
Educate participants and families on study requirements and procedures
Serve as liaison between participants, investigators, and clinical teams
Monitor participant progress and report adverse events and protocol deviations
Prepare and submit IRB documents including:
Initial applications
Amendments
Continuing reviews
Adverse event and safety reports
Maintain regulatory binders and essential study documentation
Ensure compliance with ICH-GCP, HIPAA, and federal/state regulations
Support audits, monitoring visits, and inspections
Maintain accurate source documents and Case Report Forms (CRFs)
Enter and manage data in CTMS, EDC, and EMR/EHR systems
Respond to sponsor data queries and monitoring findings
Ensure data integrity, accuracy, and timely reporting
Coordinate investigational product (IP) accountability, inventory, and reconciliation
Work with pharmacy and clinical teams on study drug/biologic/device management
Assist with biospecimen handling, shipment, and tracking
Coordinate meetings, prepare reports, and maintain study logs
Train site staff and mentor junior research coordinators as needed
Bachelor's degree in a health, life science, or social science related field
Prior experience supporting clinical trials in a research or healthcare setting
Strong knowledge of Good Clinical Practice (GCP) and clinical research regulations
Experience with patient-facing research activities , including informed consent
Proficiency with CTMS, EDC systems, and Electronic Medical Records
Excellent documentation, organizational, and communication skills
Ability to manage multiple studies and meet deadlines in a fast-paced environment
Experience with Phase I or Phase II clinical trials
Experience in academic medical centers or government-funded research
Clinical research certification such as:
CCRC
CCRP
ACRP-CP
CCRA
Experience supporting audits, monitoring visits, or FDA inspections
Candidates with relevant clinical research experience and certifications are strongly encouraged to apply.
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