Job Description

Clinical Research Coordinator

• 100% on site
• MUST be local, NO relocation candidates
• M-F schedule
• Great opportunity to set your roots down with a growing physician-led research network

Overview:

The Clinical Research Coordinator (CRC) is responsible for reviewing, processing, and managing clinical research data and documents, both regulatory and patient records. The CRC performs a variety of clinical procedures, and assists with daily workload planning; ie; collect, record, report, and interpret data on patients enrolled in and/or seeking enrollment in clinical studies according to the protocol, company SOPs, and GCPs.

Day to day:

• Collect, record, and maintain research subject study data according to study protocols and SOPs, preserving quality control for content, accuracy, and completeness.
• Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research.
• Recruit and screen participants for clinical trials and maintain subject screening logs.
• Assist in the initial and ongoing consent process; orient research subjects to the study, including the purpose of the study, procedures, and research process.
• Maintain source documentation based on protocol requirements.
• Schedule and execute study visits and perform study procedures.
• Handle lab testing and analysis, including preparation of specimen collection tubes, shipment, and lab logistics.
• Monitor subject safety and report adverse events/reactions to the Principal Investigator and/or appropriate medical personnel.
• Correspond with research subjects and troubleshoot study-related questions or issues.
• Participate in “huddles” to confirm daily study tasks are assigned to team members and are executed to the expected standards.
• Perform a variety of complex clinical research procedures including but not limited to ECG, sample collection, spirometry, vital signs, dose verification, cannulation, and cardiac telemetry monitoring, if needed.
• Maintaining & ordering study specific supplies
• Scheduling subjects for study visits and conducts appointment reminders
• Building/updating source as needed
• Ensuring study related reports and patient results are reviewed by investigator in a timely manner
• Filing SAE/Deviation reports to Sponsor and IRB as needed, documenting and reporting adverse events
• Reporting non-compliance to appropriate staff in timely manner
• Maintaining positive and effective communication with clients and team members
• Maintaining confidentiality of patients, customers and company information,
• Complete all needed activities for study start-up, including completing required training, uploading printing certificates to file in ISF, etc.
• Prepare and attend site initiation visits (SIV’s) and Investigator Meetings (IMs), as needed
• Performs other duties and projects as assigned.

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