Clinical Research Coordinator (CRC) - Imperial Beach, California
Imperial Beach, CAFull-time
Behavioral Health Market Context
Apply Nowvia Lensa
Qualifications
- •Risks and benefits are clearly explained
- •Written informed consent is obtained prior to any study procedures
- •Maintain required certifications and stay current with clinical research standards
- •Good Clinical Practice (GCP)
- •CPR Certification
- •Human Subjects Protection training (CITI or equivalent)
- •Continuing education is encouraged
- •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)
- •8 more items(s)
Responsibilities
- •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
- •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
- •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
- •Identify and recruit eligible study participants from the site's patient population
- •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
- •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
- •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
- •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
- •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
- •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
- •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
- •Maintaining audit readiness
- •Ensuring protocol compliance
- •Following internal standard operating procedures
- •Supporting internal quality reviews
- •Training and Professional Development
- •67 more items(s)