Clinical Research Coordinator

About the role

The Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant study conduct according to all relevant local, federal, and state regulatory and institutional Policies and Standard Operating Procedures. This role carries out the research and works under the general supervision of the principal investigator responsible for the clinical trial(s) to which is assigned.

Responsibilities

• Acts as liaison between principal investigators, sub-investigators, clinical research nurses and regulatory specialists on all regulatory issues and changes within the protocol.
• In collaboration with the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies for feasibility and evaluates potential competition with other protocols prior to submitting study.
• Reviews study with principal investigator and/or clinical research nurses to a budget outlining standard of care and research costs. Finalizes budget draft with budget coordinator.
• Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks. Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
• Covers research activities not limited to: scheduling laboratory tests, radiology testing and other medical exams as required.
• Works with the study team to draft/create study specific study orders, billing templates and study calendars as necessary.
• Schedules subjects for appointments, procedures, or inpatient stays as required by study protocols.
• Maintains compliance with protocols and regulatory requirements throughout study activities.
• Registers protocol patients with appropriate statistical centers as required.
• Tracks enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
• Communicates with sponsors and monitors to address issues and ensure compliance.
• Maintains accurate, complete, up-to-date records on each protocol and each patient participating in a clinical trial protocol in the clinical trial management system and all other systems as required.
• Coordinates study-related documentation and prepares for quality assurance audits.
• Collaborates with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.

Qualifications

• BA/BS diploma/degree in science or healthcare field.
• Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field of clinical research.
• Strong attention to detail and customer service focus.
• Excellent organizational, presentation, documentation and interpersonal skills.
• Excellent written and verbal communication skills.
• Proficient computer skills that include but are not limited to Microsoft Office and/or Google Suite platforms.