Job Description:
The CRC will coordinate effective communication between data management and CRO to ensure timely design and delivery of CRFs, database(s), and the data management plans. Understand and implement clinical protocols, CRFs, and other documents pertinent to study conduct day-to-day tasks of defined aspects of the study, such as recruitment activities, randomization, study visits and close follow up with each subject screened and enrolled in the study. Archive completed studies per SOP’s. Participate in pre-study, site selection, site initiation, interim monitoring, and study close-out visits in accordance with SOPs Review clinical data, generate project management reports, and assist in the preparation of clinical study reports. Monitor and conduct clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines and company SOPs in support of new drug implications. Support project teams in the placement, implementation, evaluation and conclusion of clinical studies, as stipulated in the monitoring plans. Develop a rapport with, Monitors, Sponsors and or CRO’s to facilitate the placement of future research studies. Work closely with principal investigator and sub-Investigator to ensure compliance for each protocol. Strong experience generating correspondence and reports without administrative help, making one’s own travel arrangements, general clerical duties associated with managing a physician’s practice and the ability to anticipate, trouble shoot and resolve various types of problems and issues. Be able to multitask and work well in high stress environment. Be able to train new interns, medical assistants or research assistants. Follow GCP, ICH, & SOP’s at all times.
Position requirements: Candidates must have a bachelor’s degree, preferably in a scientific or nursing discipline. Must have 3 years’ experience in a pharmaceutical or CRO setting functioning as a CRC and or a master’s degree in a science discipline with a minimum of one year of research internship.
Please email resume to: [email protected]
