needed for managing and helping build a dedicated research center. The position includes clinical coordination, assisting clinical investigators and research staff to drive projects forward by interacting closely with external clinical research organizations and sponsors.
The Clinical Research Coordinator will adhere to GCP, ICH, and FDA guidelines in the conduct of all study related activities.
Duties and Responsibilities:
Knowledge, Skills and Abilities:
- Provide study coordination for assigned trials as directed by the Site Director; including data coordination and quality control of research data.
- Complete regulatory paperwork for IRB submissions, annual reviews and study close-out.
- Ensure that all Serious Adverse Events (SAEs) are reported in a timely fashion to IRB and sponsor.
- Assist with monitoring visits.
- Interact/liaise with study sponsors and investigators in role of study representative.
- Assist with the screening of patients for study eligibility, conducting screening interviews over the phone and/or in person and the development and implementation of rapid recruitment methods and fulfillment of enrollment goals.
- Schedule study patient appointments and make reminder calls to patients; send reminder letters and emails as appropriate.
- Conduct study patient visits per protocol, including screening and follow-up visits, data collection and entry, specimen collection, and other study activities.
- Create and update paper and electronic study patient records.
- May be asked to attend Investigator Meetings for new trials as assigned.
- Perform other duties as assigned.
Preparation of all study documentation such as protocols, amendments, case report forms, SAE reports and study reports are an integral part of this job.
Ideal candidate will have several years prior experience as a Clinical Research Coordinator , CCRC preferred.
This position requires strong organizational, project management and communication skills in addition to the ability to manage multiple projects simultaneously. Working knowledge of medical terminology is highly preferred and ideal candidate must be familiar with the regulations, standards and guidance governing the conduct of clinical studies. The ideal candidate must also have the ability to verbally communicate effectively with physicians, nurses, pharmaceutical companies and other team members.
All responders please forward CV, salary requirements, and availability.
Bilingual a plus
Only motivated, self-starters need apply. Applicants must be capable of independently driving their studies.