Clinical Trial Study Coordinator 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.
Requirements
Minimum Qualifications:
Bachelor's degree in life sciences, nursing, public health, or a related field preferred; or a minimum of 2 years of relevant clinical research experience.
Prior experience in clinical trial coordination or a similar role preferred.
Current certification in Human Subject Protection (HSP) and Good Clinical Practice (GCP), or ability to obtain within 5 business days of employment.
Experience with clinical trial management systems and regulatory compliance.
Strong written and verbal communication skills.
Ability to manage high-pressure situations with professionalism.
Physical Requirements / Working Conditions:
Environment: Primarily office/research setting with temperature control. Occasional visits to clinical areas and laboratories may be required.
Physical Requirements:- Prolonged periods of sitting; walking, standing, bending, or lifting (up to 30 pounds).Manual dexterity for computer work and handling documents.
- Visual and auditory ability sufficient for written and verbal communication.
- May occasionally require travel to off-site study locations or meetings.
- Essential Physical Tasks:
- Sight – sufficient to read physical documents, and images on a computer monitor.
- Smell – sufficient to discern smoke/something burning, and other odors.
- Hear – sufficient to hold face to face/telephone/video call conversations, and to discern other ambient noises.
- Touch – sufficient to operate keyboard, mouse, other standard office equipment, and writing implements.
- Physical ability/strength – sufficient to lift, twist, turn, reach, climb, kneel, squat, sit, walk, stand, bend as needed throughout a standard shift.
