This position will act as the departmentâ??s internal and external clinical research monitor; performing quality assurance reviews, auditing and ensuring compliance with clinical protocols, local and federal laws and regulations, as well as Good Clinical Practice (GCP). This position will also provide support on IND clinical research studies pertaining to data review, querying and data entry. Other responsibilities related to the office and trial maintenance as necessary.
- Bachelors Degree with~ 3 years clinical research experience including experience with CRO/sponsor monitoring/auditing in pharmaceutical industry or equivalent combination of education/related experience. Oncology monitoring experience preferred.
- Working knowledge of disease state and an understanding of regulatory requirements.
- Knowledge of study protocols and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.)
- In depth knowledge of GCP regulations, 21CFR regulations, IND and IDE processes, quality systems, quality assurance, quality control and GCP quality audits.
- Experience in regulatory inspections, vendor audits, and vendor qualification, and internal audits.
- Excellent interpersonal/communication skills (verbally and in writing)
- Proficiency with Microsoft Office (Excel, Word, Project, PowerPoint).
- Ability to work effectively both independently and as part of a team.
- Detail oriented and excellent organizational skills.
- Professional demeanor and the ability to work effectively in a (sometimes) dead-line driven environment.
- Willingness to travel to in-state site locations .
- Willingness to work some (occasional) weekends when necessary.
CRIMINAL BACKGROUND AND EDUCATION CHECK REQUIRED
Recruiting Start Date:2016-12-12-08:00
Job Posting Title:Clinical Research Monitor and Regulatory Specialist
Time Type:Full time
Scheduled Weekly Hours:37.5
Please note that in order to be considered an applicant for any staff position at Brown University you must submit an application form for each position for which you believe you are qualified. Applications are not kept on file for future positions. Please include a cover letter and resume with each position application.
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