What are the responsibilities and job description for the CRA - Monitor West/Mountain position at System One?
Oncology Clinical Study Monitor- PART TIME
Key responsibilities-- general site management, including but not limited to:
Key responsibilities-- general site management, including but not limited to:
- Ensuring sites meet study qualifications, monitoring of assigned study sites according to the monitoring plans, ensuring timely data submission and query resolution.
- Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, Global and local regulations to secure data integrity and patient safety.
- Frontline liaison for Sponsor and sites to ensure successful collaboration.
- Responding to site questions, and preparation of reports.
- The study monitor will be an integral part of the study team matrix and will also need to prepare for and participate in calls/meetings.
- Candidate should expect to travel approximately 60% of the time. A valid driver’s license will be necessary.
- The candidate must have a strong health-care related background with a college degree or be a graduate of an accredited school of nursing. At least five years prior to oncology monitoring experience is required with hematology study experience multiple myeloma and small cell lung cancer backgrounds
- The candidate must demonstrate professionalism, exemplary planning skills, and be able to work with autonomy and minimal supervision.
- Good communication skills, identification of key issues and trends, and problem-solving are integral to success in the position.
- Knowledge of ICH, GCP, safety and other regulatory requirements is key; certification from SOCRA or ACRP is preferred.
- He/she must have computer competency and should be familiar with data management systems (i.e., Medidata RAVE).
- Experience in related fields such as pharmaceutical, data management, and technical writing is a plus.