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Clinical Research Associate
2 months ago
Position Overview
ICON Strategic Solutions is seeking dedicated Clinical Research Coordinators to join our dynamic team.
Role Summary
The Clinical Research Coordinator plays a crucial role in ensuring the safety and well-being of study participants. This position is essential in promoting the mission of our organization to operate as an Integrated Site Network. The coordinator will actively engage in recruiting suitable participants and liaising with sponsor representatives while executing tasks necessary for the successful coordination and completion of clinical studies.
Key Responsibilities
- Develop and maintain the necessary skills to adhere to study protocols, federal regulations, internal standard operating procedures (SOPs), and guidelines.
- Execute study initiation tasks, including crafting recruitment strategies, creating recruitment tools, and conducting participant phone screenings.
- Complete training on the Clinical Trial Management System, ensuring proficiency in updating databases, processing participant reimbursements, and generating recruitment call lists.
- Maintain open communication with the Clinical Operations Manager regarding training, recruitment efforts, and overall trial status.
- Participate in investigator meetings and contribute to the development and revision of source documents and progress notes.
- Accurately gather study data through source documents as mandated by the study protocol.
- Conduct technical procedures as outlined in the study protocol, including laboratory work, vital sign assessments, and other necessary evaluations.
- Continuously review participant eligibility criteria throughout the screening phase.
- Document laboratory results and adverse events, promptly reporting serious incidents to the investigator, Institutional Review Board, and sponsor.
- Foster strong relationships with investigators, providing regular updates on trial progress and participant status.
- Dispense study medications under the direction of the investigator.
- Maintain consistent communication with the study monitor through various forms of contact.
- Enter visit data into the Electronic Data Capture (EDC) system or Case Report Forms (CRF) within the timelines established by the sponsor.
- Address all data queries within 48 hours of receipt.
- Collaborate with the Clinical Research Associate during monitoring visits to resolve queries and clarify data as needed.
- Report any protocol violations or significant deviations to the Clinical Operations Manager.
- Engage with participants to educate them about the clinical trial process and assist with informed consent.
- Support team members as required, adapting to the evolving needs of the research organization.
- Anticipate potential challenges in job responsibilities and propose solutions aligned with our mission.
- Prepare study documentation for audits and assist auditors throughout the process, ensuring timely resolution of discrepancies.
- Travel to other sites within the network may be necessary to accommodate workload demands.
