Study Coordinator

About the Role As the Study Coordinator you will plan the execution and monitor the completion of complex Phase I‑IV assigned clinical research protocols. Responsibilities Abstract, assemble, and organize research data while monitoring adherence to the clinical protocol and preparing reports on the data. Work closely with the physician principal investigator, manager of data operations, clinical trial sponsor, and study team. Lead the execution of trials for the research team. Plan and track all assigned clinical activity through the startup, interim, and close‑out phases. Confirm patient eligibility and discuss discrepancies with nursing staff and physicians. Verify study procedures are performed within the protocol‑specified window. Participate in teleconferences with sponsors to update on patients, including research visits, toxicity, and overall response. Send notification to the department before and after calls to update study staff. Present at weekly protocol meetings to investigators, research staff, and management. Provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria. Update internal research teams on protocol modifications and specifications, including visit schedule, assessment windows, dose modifications, central and local laboratory assessments. Create study‑specific tools for source documentation, such as eligibility worksheets, screening checklists, and worksheets capturing vital signs and blood sampling. Ensure study‑specific tools, including source documents, are updated with any amendments or study changes. Investigate root cause of major protocol deviations and follow up with responsible departments for corrective and preventive actions. Ensure pharmacy has Investigative Product and supplies. Interface with laboratory technician for lab kits and processing. Track and report adverse events, serious adverse events, protocol waivers, deviations, and violations. Participate in monitor visits for each assigned trial at each monitoring visit. Review and comment on monitor letters within 5 business days of receipt and ensure resolution of open items. Review source documentation and queries for missing documentation. Collect, complete, and enter data into study‑specific case report forms or electronic data capture systems within the contractually agreed timeframe. Maintain case report form tracking and management database. Review trial data for clinical relevance and respond to appropriate queries. Inform research scientists and management team of all study‑specific medical issues for guidance. Assist in ensuring physician oversight by updating on protocol issues, obtaining signatures, and assessing the clinical significance of laboratory reports, ECGs, and adverse events. Assist in external sponsor audit and US FDA inspection preparation, conduct, and close‑out procedures. Review and respond to audit findings and elevate issues. Maintain and archive study documentation and correspondence per company policy. Report patient visit and data entry information in the financial tracking system. Provide required metrics to leadership. Initiate improvements to enhance the efficiency and quality of work performed on assigned projects. Adhere to professional standards and SOPs established for clinical research. Assist the internal quality team in preparation for sponsor and US FDA audit teams. Qualifications Understanding of clinical trial data. Knowledge of FDA guidelines and Good Clinical Practice (GCP) required. Ability to work independently in a fast‑paced environment. Interpersonal skills, detail‑oriented, and meticulous. Computer skills with ability to use clinical trial databases, electronic data capture, MS Access, or Excel. Bachelor’s degree preferred. At least one year of experience in healthcare, research, or other science‑related field. At least one year of experience planning and managing the clinical trial process. Benefits The role is part of a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well‑being. Compensation is competitive and may include base pay, annual bonuses, and long‑term incentive opportunities, determined by factors such as performance, experience, skills, equity, and geographic market. Equal Opportunity Employer We are an equal‑opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. #J-18808-Ljbffr