Description
- RESPONSIBILITIES: Assist in the development and tracking of study timelines and budgets; Coordinate other study-wide activities such as sample handling, drug re-supply, and investigator payments; Assist in maintaining a complete and updated regulatory file for each assigned site; Partner with Data Management to ensure that data at site(s) and study levels are reviewed; Assist in the development of key study documents, including Protocols and amendments, Final Study Reports, Monitoring Plans, and site educational and reference materials; Participate in teleconferences with CROs and Clinical group; Site monitoring including collecting, processing, and reviewing case report forms; Assists with the overall planning, development, and data management of one or more clinical investigations, including the preparation, writing, and completion of required documents.
- EDUCATION / EXPERIENCE:
- Bachelors in biological sciences, nursing or other related discipline
- Clinical research experience within the biotech/pharmaceutical industry, in women's health highly desirable, with a minimum of 1 year of clinical research and co-monitoring experience required.
- Knowledge of medical practice, techniques and terminology.
- Knowledge of US and GCP/ICH regulations governing clinical trials.
- Organized and detail-oriented individual with excellent writing, analytical, technical and interpersonal skills.
- Proficiency in Microsoft Word, Excel, Outlook, Power Point and Adobe Acrobat
To find out more about Real please visit www.realstaffing.com