Brown University Clinical Research Monitor and Regulatory Specialist in Providence, Rhode Island
The Clinical Research Monitor and Regulatory Specialist position will act as the department’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 Investigational New Drug ( IND) clinical research studies pertaining to data review, querying and data entry. Other responsibilities related to the office and trial maintenance as necessary.
The Brown University Oncology Research Group (BrUOG) is the principle mechanism for oncology clinical trials at The Warren Alpert Medical School. This regional consortium of Brown-affiliated hospitals allows hematologists, oncologists, surgeons, radiation oncologists, pathologists, and others to develop investigator-initiated clinical trials. These studies are conceived and designed by faculty at member institutions. They provide cutting-edge applications of chemotherapeutic agents, biologic agents, and other treatment modalities. Such innovative studies lay the groundwork for larger nationwide studies under the auspices of cooperative clinical trials groups.
Education and Experience
Required: Bachelor’s degree with 3-5 years’ clinical research experience or equivalent combination of education/related experience.
Preferred: Experience with CRO/sponsor monitoring/auditing in pharmaceutical industry
Required: Oncology monitoring experience .
Required: Working knowledge of disease state and an understanding of regulatory requirements
Required: Knowledge of study protocols and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.)
Required: In depth knowledge of GCP regulations, 21CFR regulations, IND and IDE processes, quality systems, quality assurance, quality control and GCP quality audits.
Required: Experience in regulatory inspections, vendor audits, and vendor qualification, and internal audits
Preferred: ACRP or SOCRA certification.
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
Possesses a willingness and ability to support and promote a diverse and inclusive campus community
BACKGROUND AND EDUCATION CHECK REQUIRED
Recruiting Start Date:
Job Posting Title:
Clinical Research Monitor and Regulatory Specialist
Brown University Oncology Group
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Founded in 1764, Brown is a leading institution for education, discovery, and global intellectual progress as well as one of the largest employers in Rhode Island. Working at Brown brings more than just a paycheck and generous benefits; it offers an opportunity to contribute to a greater good. Join us in supporting the pursuit of knowledge and individual growth that defines higher education and enriches our community.
Information about our salary ranges can be found here (https://www.brown.edu/about/administration/human-resources/compensation-services/salary-ranges) .
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