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Clinical Research Coordinator (CRC)
Position Summary
Mon-Fri, Flexible Schedule
Oversight of ~3 Study Sites
The Clinical Research Coordinator (CRC) is responsible for the day-to-day coordination and operational execution of clinical trials conducted within outpatient healthcare settings.
The CRC ensures that clinical trials are conducted in accordance with:
- ICH Good Clinical Practice (GCP)
- FDA regulations
- Institutional Review Board (IRB) requirements
- Sponsor protocols
- Internal Standard Operating Procedures (SOPs)
The CRC serves as the primary operational liaison between study participants, the Principal Investigator (PI), sponsors or Contract Research Organizations (CROs), and internal leadership. The role focuses on ensuring patient safety, regulatory compliance, data integrity, and successful study execution.
Reporting Structure
The Clinical Research Coordinator reports to operational leadership within the research program.
Clinical oversight is provided by the Site Principal Investigator (PI).
Study Start-Up and Site Preparation
Assist with the preparation and activation of clinical trials at assigned healthcare sites.
Responsibilities include:
- Reviewing study protocols and investigator brochures
- Assisting with site feasibility assessments
- Preparing regulatory binders and study documentation
- Coordinating site initiation visits
- Ensuring required equipment and study supplies are available
- Assisting with IRB submissions and regulatory documentation
- Coordinating staff protocol training
Participant Recruitment and Screening
Identify and recruit eligible study participants from the site’s patient population.
Responsibilities include:
- Conducting electronic health record (EHR) pre-screening
- Collaborating with clinical staff to identify potential participants
- Coordinating with providers to approach eligible patients
- Explaining study participation requirements
- Scheduling screening and enrollment visits
Informed Consent Process
Assist the Principal Investigator in ensuring that:
- Participants fully understand the study
- Risks and benefits are clearly explained
- Written informed consent is obtained prior to any study procedures
- Ensure all consent documentation is completed and maintained in accordance with regulatory standards.
Study Visit Coordination
Coordinate all participant study visits in accordance with study protocols.
Responsibilities include:
- Scheduling visits per protocol requirements
- Conducting protocol-required assessments
- Collecting clinical data
- Recording vital signs and medical history updates
- Administering study questionnaires
- Ensuring protocol adherence
Specimen Collection and Handling
Responsible for proper collection, processing, and shipment of biological samples.
Responsibilities include:
- Processing blood and urine samples
- Ensuring proper labeling and documentation
- Preparing shipments according to sponsor laboratory requirements
- Maintaining specimen tracking logs
Data Collection and Documentation
Ensure that all study data is accurate, complete, and properly documented.
Responsibilities include:
- Maintaining source documentation
- Completing Case Report Forms (CRFs) or electronic data capture (EDC) entries
- Resolving sponsor data queries
- Maintaining regulatory binders and essential documents
Participant Safety Monitoring
Monitor participant safety throughout the study.
Responsibilities include:
- Monitoring participants for adverse events or side effects
- Reporting adverse events to the Principal Investigator
- Ensuring timely reporting to sponsors and IRBs
- Maintaining safety documentation
Sponsor and CRO Communication
Serve as the operational point of contact for sponsors and CROs.
Responsibilities include:
- Participating in monitoring visits
- Preparing documentation for audits and inspections
- Responding to sponsor queries
- Providing updates on study progress
Quality Assurance and Compliance
Ensure all study activities meet regulatory and quality standards.
Responsibilities include:
- Maintaining audit readiness
- Ensuring protocol compliance
- Following internal standard operating procedures
- Supporting internal quality reviews
Training and Professional Development
Maintain required certifications and stay current with clinical research standards.
Required certifications include:
- Good Clinical Practice (GCP)
- CPR Certification
- Human Subjects Protection training (CITI or equivalent)
- Continuing education is encouraged.
Required Qualifications
- Bachelor’s degree in health sciences, nursing, biology, public health, or related field
- Minimum of 2 years of clinical research experience required
- Experience working in healthcare or clinical environments
- Knowledge of clinical research regulations and Good Clinical Practice (GCP)
- Bilingual (English and Spanish) is a plus!!