Clinical Research Coordinator II
Clinical Research Coordinator II
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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.
Key Responsibilities:
Oversee Clinical Trials: Ensure smooth operations of 34 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.
Requirements:
Education: Bachelor s degree in a healthrelated field preferred.
Experience: 2 years of experience in clinical research.
Regulatory: Familiarity with study document filing submission assistance and conducting closeout 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.
Working Conditions:
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).
Employment Type
Full Time
