Description
Major Duties and Responsibilities:- planning, designing, and executing clinical research trials
- manage several investigational sites from trial start to finish with limited supervision
- travelling to investigational sites, observing and preparing reports as required, and ensuring proper collection of data
- train and advise clinical study coordinators on the collection of clinical data, data entry into EDC system and good documentation practices
- conduct regular visits at investigational sites to monitor study activities and assure adherence to study protocols, company SOPs, and compliance to GCP guidelines, FDA regulations and IRB requirements
- conduct study qualification, initiation, and close out visits
- prepare site visit reports as required
- participate in developing and managing study budgets
- train, mentor, and advise other junior CRAs
- attend relevant scientific and/or medical meetings as directed
Education / Experience required:
Minimum BS Degree preferrably in Life Sciences or related field. RN or other professional degree highly desirable. Certification in clinical trial conduct is preferred.
3-5 years of experience conducting industry-sponsored clinical trials, preferrably with medical devices in the Ear, Nose, and Throat space involving surgery. Must demonstrate experience managing at least 2 trials from start to closure, experience with data collection and monitoring using EDC, working knowledge of clinical research methodology, GCPs and ICH guidelines, FDA regulations, and experience in clinical trial audits preferred.
Must posess excellent communication skills, both written and verbal, including presentation skills. Position requires excellent interpersonal, managerial, and organization skills. Attention to detail required. Ability to travel 50% - 80% requried.
To find out more about Real please visit www.realstaffing.com