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Clinical Research Coordinator
2 months ago
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 protocol and maintaining effective communication with our team.
Key Responsibilities- Study Coordination: Develop and maintain proper skills to comply with the protocol, federal regulatory requirements, internal SOP's, and COG's.
- Recruitment and Screening: Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants.
- Data Management: Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment.
- Communication: Communicates with the Manager of Clinical Operations regarding training/orientation, recruitment efforts, the overall status of a trial(s), and other concerns.
- Investigator Meetings: Attends investigator meetings.
- Source Document Management: Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines.
- Lab Work: 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.
- Monitoring Visits: Meets with the Clinical Research Associate at each scheduled monitoring visit and is available to complete queries or data clarifications in timely manner during these visits.
- 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.
- Problem Anticipation: Anticipates possible problems and resolutions with job responsibilities as these responsibilities apply to our mission statement.
- 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.
