Clinical Research Coordinator (CRC) - Imperial Beach, California

i4 Search Group Healthcare

Imperial Beach, CAFull-time

Behavioral Health Market Context

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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)
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