- The CRC will coordinate effective communication between data management and CRO to ensure timely design and delivery of CRFs, database(s), and 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: ndeen@clinicalresearchacademy.com
