Clinical Research Coordinator

2 weeks ago

Columbia, South Carolina, United States ICON Strategic Solutions Full time
Job Summary

ICON Strategic Solutions is seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our team. As a Clinical Research Coordinator, you will play a critical role in ensuring the success of our clinical trials by coordinating and completing studies according to protocols.

Key Responsibilities
  • Study Coordination: Ensure the safety of our volunteers, promote the mission of ICON Strategic Solutions, and consistently strive to meet and exceed priorities as discussed with direct supervisor.
  • Recruitment and Promotion: Actively recruit and promote our service to suitable participants and sponsor representatives.
  • Protocol Compliance: Develop and maintain proper skills to comply with the protocol, federal regulatory requirements, internal SOP's, and COG's.
  • Database Management: Complete training on Clinical Trial Management System and maintain proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.
  • Communication: Communicate with the Manager of Clinical Operations regarding training/orientation, recruitment efforts, the overall status of a trial(s), and other concerns.
  • Investigator Meetings: Attend investigator meetings.
  • Source Document Management: Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines.
  • Data Collection: Accurately collects study data via source documents/progress notes as required by the protocol.
  • Technical Requirements: Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol.
  • Continuous Review: Performs continuous reviews of the inclusion and exclusion criteria for each participant during the screening period.
  • Documentation: Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events.
  • Relationship Building: Builds strong relationships with Investigators and provides ongoing communication about trial status and participants.
  • Medication Dispensing: Dispenses study medication at the direction of the Investigator.
  • Communication with Sponsors: Maintains communication with the monitor from the sponsoring company through telephone contact, written communication, and on-site visits.
  • Data Entry: Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor.
  • Query Resolution: Addresses all queries or data clarifications within 48 hours of receipt.
  • Protocol Violations: Reports protocol violations and significant deviations to the Manager of Clinical Operations.
  • Patient Education: Establishes relationships with volunteers, and participates in patient education regarding the clinical trial process and provides specific trial information to the participant as well as conducting the informed consent process.
  • Team Support: Assists other staff members as determined by the needs and priorities of the research organization and as time and abilities permit.
  • Audit Preparation: Prepares study documentation in the event of a PMG, sponsor, or FDA audit and assists the auditor for the duration of the audit including correcting discrepancies in a timely manner.
  • Travel: Travel to other sites within the network may be required to support increases in workload and, or studies/projects as needed.

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