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Clinical Research Specialist
2 months ago
ICON Strategic Solutions is seeking Clinical Research Coordinators.
Position Overview
The Clinical Research Coordinator plays a pivotal role in ensuring the safety and well-being of study participants. This position is integral to the mission of ICON to operate as a cohesive Integrated Site Network. The Coordinator is responsible for actively recruiting suitable participants and liaising with sponsor representatives, while ensuring compliance with study protocols.
Key Responsibilities
- Develop and maintain expertise in adhering to study protocols, federal regulations, and internal standard operating procedures.
- Conduct study initiation tasks, including creating recruitment strategies and screening potential participants.
- Utilize the Clinical Trial Management System effectively to manage participant data and reimbursement processes.
- Maintain open communication with the Clinical Operations Manager regarding training, recruitment, and trial progress.
- Participate in investigator meetings and contribute to the development of source documents and progress notes.
- Accurately gather and document study data in accordance with protocol requirements.
- Perform necessary technical tasks as outlined in the study protocol, including laboratory procedures and health assessments.
- Continuously evaluate participant eligibility throughout the screening phase.
- Document and report any adverse reactions or laboratory results to the appropriate parties promptly.
- Foster strong relationships with investigators and provide updates on trial status and participant engagement.
- Dispense study medications under the guidance of the investigator.
- Engage with monitors from sponsoring organizations through various communication methods.
- Ensure timely entry of visit data into Electronic Data Capture systems.
- Address data queries and clarifications promptly during monitoring visits.
- Report any protocol deviations to the Clinical Operations Manager.
- Educate participants about the clinical trial process and facilitate informed consent.
- Assist colleagues as needed, adapting to the evolving priorities of the research organization.
- Anticipate potential challenges and develop solutions relevant to job responsibilities.
- Prepare documentation for audits and assist auditors as necessary.
- Travel to other sites may be required to support operational needs.
