About the job
As a Clinical Study Coordinator, you will play a vital role in supporting a medical institution with clinical trial-related tasks. You will work closely with the Principal Investigator to ensure compliance with local and federal regulations while leveraging competencies developed through Milestone One. Your responsibilities will encompass evaluating the feasibility of potential clinical studies, coordinating research visits according to study protocols, and facilitating smooth patient flow during these visits. You will also be involved in logistics, data entry, and maintaining communication with CRO or sponsor representatives to address study-specific issues. Additionally, you may mentor junior staff and handle administrative duties as assigned by your manager.
Key Responsibilities:
- Serve as a primary communication link between Milestone One, sponsors, CROs, and the medical institution.
- Facilitate the assessment of proposed studies, ensuring timely responses to feasibility inquiries.
- Engage in patient recruitment and eligibility evaluation in line with inclusion and exclusion criteria.
- Assist in developing recruitment and retention strategies to optimize research staff efficiency.
- Support the local research team in obtaining informed consent from participants.
- Ensure that necessary assessments are completed at each visit, alerting the investigator of critical values that may affect study treatment.
- Manage laboratory testing, processing, and shipping per study protocols.
- Coordinate sponsor and CRO representative visits, prepping the site for effective engagement.
- Monitor patient recruitment and enrollment progress, providing regular updates to the team and investigators about study amendments.
- Guarantee accurate and timely data entry into electronic data capture (EDC) systems, addressing data queries, and assisting with adverse event reporting as per guidelines.
- Support the proper handling, accountability, and documentation of study materials and data.
