CRA - Monitor West/Mountain
system one holdingsCoatesville, PA
CRA - Monitor West/Mountain
system one holdingsCoatesville, PASenior L5
All Other Outpatient Care CentersSpecialty (except Psychiatric and Substance Abuse) HospitalsGeneral Medical and Surgical Hospitals
APPLY NOWOncology Clinical Study Monitor- PART TIMEKey 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.
Experience:
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.
Ref: #568-Clinical
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Level
Senior L5
Location
Coatesville, PA
Occupation
Clinical Research Coordinators
Industry
All Other Outpatient Care Centers
Posted
2 days ago