Clinical Research Coordinator

Job Title

Clinical Research Coordinator (Clinical Trials)

(Phase I / II | Patient-Facing | Regulatory & Data Focused)

Job Type

Full-Time | 30 40 hours per week

Location

Onsite Bethesda, MD (No remote option)

Role Overview

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 .

Key Responsibilities Clinical Trial Coordination

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

Participant Management & Informed Consent

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

Regulatory & Compliance

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

Data Management & Documentation

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

Trial Operations & Collaboration

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

Required Qualifications

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

Preferred Qualifications

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.