Job Description
Summary:
The Clinical Research Coordinator II is responsible for managing and overseeing clinical trials, working closely with a team under the direction of the Site Operations Manager. This role ensures smooth trial operations, participant monitoring, and data collection while maintaining compliance with protocols and regulatory standards.
Oversee Clinical Trials: Ensure smooth operations of 3-4 clinical trials, monitor participant health, and compile trial outcome reports.
Data Collection and Analysis: Collect and analyze data from research studies.
Participant Interaction: Communicate study objectives to participants, administer questionnaires, and monitor adherence to study protocols.
Collaboration and Compliance: Liaise with labs, monitor compliance with protocols, and ensure regulatory adherence.
Record Keeping: Maintain comprehensive research records, including case report forms and drug dispensation records; manage specimen collection and storage.
Logistics and Supplies: Ensure equipment and supplies are available and operational.
Education: Bachelor’s degree in a health-related field preferred.
Experience: 2+ years of experience in clinical research.
Regulatory: Familiarity with study document filing, submission assistance, and conducting close-out visits.
Finance: Manage stipend payments.
Subject Interaction: Experience in recruiting, interviewing, screening, enrolling, randomizing subjects, obtaining informed consent, collecting medical history, and conducting study visits.
Administrative: Proficiency in source documentation, electronic data capture (EDC), query resolution, AE/SAE documentation, protocol violation management, and supply ordering.
Clinical Skills: Competency in phlebotomy, vital signs monitoring, and ECG.
This role typically operates Monday through Friday, 8:00 a.m. to 5:00 p.m., with potential for overtime. Physical demands include prolonged walking, standing, and manual dexterity for operating office equipment. Normal hearing and eyesight are required for reporting.
Travel: As needed, including possible travel to investigator meetings (IMs).
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