Clinical Trial Study Coordinator

Job Title: Clinical Trial Study Coordinator
Department: Administration/Clinical Trials
Reports To: Clinical Trial Director
Job Type: Full-Time
Location: NVEC – North Valley Eye Care

Pay Range: $27-31 per hour

Job Summary:

The Clinical Trial Study Coordinator plays a key role in the execution and oversight of clinical research studies at the site level. This position serves as the primary liaison between research participants, investigators, and sponsors to ensure that trials are conducted in accordance with regulatory requirements, study protocols, and ethical standards. The Clinical Trial Study Coordinator supports participant safety and ensures the integrity and quality of trial data.

Essential Functions:

• Participant Screening, Recruitment, and Enrollment: Identify eligible participants and guide them through the enrollment process, including informed consent and perform subjects testing as required by the protocol.
• Informed Consent Process: Ensure accurate and thorough completion of consent forms and compliance with California Bill of Rights.
• Study Visit Coordination: Schedule and organize participant visits for screening, follow-ups, and lab appointments as per study protocol.
• Protocol Implementation: Execute study protocols consistently and accurately, maintaining compliance with all sponsor and regulatory requirements.
• Data Collection and Management: Collect, enter, and maintain study data with a high degree of accuracy and attention to detail.
• Participant Monitoring and Follow-Up: Monitor participants for adherence to the study protocol and report adverse events or changes in condition as needed.
• Regulatory Compliance: Ensure adherence to ICH-GCP, FDA regulations, and institutional policies.
• Communication and Documentation: Maintain clear and timely communication with sponsors, CROs, and the research team; accurately document study procedures and participant interactions.
• Questionnaire Administration: Administer and collect participant-reported outcomes or quality-of-life questionnaires.
• Medication and Procedures: As needed, dispense investigational products, take and record vital signs, and perform other protocol-required assessments within scope.
• Record Maintenance: Maintain accurate and complete regulatory binders, participant records, and study documentation.
• Meeting Attendance: Participate in investigator and study team meetings as directed by the PI or Clinical Trial Director.
• Confidentiality & Ethics: Maintain participant confidentiality and uphold ethical standards throughout all trial activities.

Knowledge, Skills, and Abilities:

• Strong understanding of clinical research practices and regulatory guidelines (e.g., ICH-GCP).
• Familiarity with clinical trial documentation and data management systems.
• Knowledge of medical terminology and human subject research ethics.
• Excellent interpersonal and communication skills.
• Highly organized with strong attention to detail.
• Effective time management and problem-solving skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in Microsoft Office Suite and electronic data capture systems.
• Flexibility and adaptability to shifting priorities.