CEDENT- Clinical Research Coordinator II (Phoenix, AZ)

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 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.

Requirements:

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.

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).

Department: Direct Clients
This is a full time position

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