Clinical Research Coordinator

Clinical Research Coordinator (Clinical Trials)
(Phase I/II Patient-Facing Regulatory & Data Focused)

Full-Time 30 40 hours per week

Onsite Bethesda MD (No remote option)

We 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.

• Coordinate 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

• Bachelors 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.