Study Coordinator

Our client, a clinical research and healthcare firm is looking to bring on a Study Coordinator to handle clinical research projects including a large upcoming project.

• Thorough examination and comprehension of the project protocol.
• Facilitation of participant enrollment in studies, including identifying suitable candidates, verifying eligibility before scheduling appointments, coordinating participant visits, and direct involvement in visits where necessary.
• Efficient planning for monitoring participant visits.
• Analysis and decision-making concerning the management of allocated research protocols, including ongoing assessment of protocol adherence and promptly addressing any deviations.
• Ensuring accuracy and version control of Informed Consent Form (ICF).
• Communication with various stakeholders (Monitors/CRO/Sponsors) to address and resolve study related concerns.
• Act as a knowledgeable resource for protocol requirements for the healthcare team members.
• Offering insightful advice on the research process and team performance through weekly review meetings. • Leading necessary staff training and documentation.
• Formulating and revising Unit Rules and Guidelines to maintain adherence to site SOPs.
• Updating and/or developing Standard Operation Procedures (SOPs) when required.
• Making suggestions for participant recruitment strategies.
• Guaranteeing an organized and efficient team environment.
• Leading, guiding and training staff in related work.
• Ensuring the accuracy of source documentation through review and reconciliation
• Updating and maintaining participant enrollment logs and submitting to relevant stakeholders.
• Curating investigational product-related concerns where no pharmacist is present.
• Managing accurate drug dosing logs where no pharmacist is available.
• Documenting all participant interactions in source documents per ICH, GCPs and Federal laws.
• Verifying accuracy of various protocol forms and documents.
• Collecting adverse events from participants for review by the Investigator or other members of the study team.
• Conducting, coordinating and ensuring the success of all monitoring visits.