Job Description

Clinical Research Coordinator

• Direct hire/permanent role
• 40 hours per week
• 100% ON SITE
• Must have 1+ years of experience within clinical research trials, and direct patient care experience (ALL must be U.S. based experience)
• NOT open to relocation candidates, MUST reside locally ~50 miles

Position Summary:

The candidate will be coordinating clinical research protocols from study start up to close out. This candidate will work closely with all research staff to collect, store and maintain data in accordance with FDA Regulations, International Council of Harmonization and Good Clinical Practices.

Responsibilities:

• Directs patient care for Clinical Research Coordinator (CRC) with newly enrolled participants.
• Assists in the preparation and processing of Institutional Review Board (IRB) research proposals, amendments, continuing review applications, and adverse event reports in accordance with institutional, departmental, and federal policies, procedures, and regulations.
• Prepares and maintains documentation required for internal use, regulatory authorities, and sponsors, both before, during, and after the conduct of clinical/translational trials.
• Participates in site visits from sponsors, regulatory authorities, and others to review research, source documentation, and research procedures.
• Procures equipment and supplies necessary to fulfill project requirements.
• Records data from source documentation and participant interaction onto case report forms (paper or electronic), ensuring accuracy, completeness, and timeliness.
• Resolves queries promptly.
• Ensures research information is collected and stored in compliance with regulations, policies, and Good Clinical Practice (GCP).
• Packages and ships study specimens (blood, urine, etc.) to sponsors or laboratories in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation.
• Assists with study completion, closeout, and archiving of study files, ensuring completeness and continuity of all study data.
• Conducts ongoing checks of clinical/translational data entered on case report forms (paper or electronic) or in reports.
• Develops and manages study budgets, monitors efficient invoicing, and ensures clinical trial billing compliance.
• Serves as an advocate for human subjects by establishing and maintaining communication with investigators, research staff, sponsors, participants, professional organizations, participant advocates, and the public regarding the protection of human research participants. Monitors trial processes and participant well-being.
• Participates in the determination of eligible candidates for study participation, ensuring fulfillment of eligibility requirements.
• Assesses and evaluates potential participants' medical and historical information to ensure appropriate subject enrollment and continued eligibility.
• Engages in open and positive communication with study participants and coworkers.
• Performs or instructs others in performing procedures for research as described in the protocol.
• Deviates from the protocol only when a subject's safety is at risk and promptly reports all deviations to the Principal Investigator and/or senior personnel to determine if a protocol amendment or safety reporting is required.
• The responsibilities listed are a general overview of the position, and additional duties may be assigned.

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