Clinical Trials Research Coord
 Lifespan | |
 United States, Rhode Island, Providence | |
 May 29, 2025 | |
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Summary: Responsibilities: Play the lead role in study protocol drafting and development regulatory affairs data management medical and technical writing budget management and budget/contract/grant administration. Collaborate with Primary Investigators and nursing staff on project feasibility and implementation of proposed projects.
Act as a mentor to junior colleagues clients and clinicians new to clinical research within the Brown University Health system in the successful operational launch and completion of assigned projects. Mentors and assists subordinate clinical research staff in the execution of clinical research studies.
Maintain/continue to develop technical aptitude in the functional operation and maintenance the research study alongside the Principal Investigator by attending instructional training conducting literature reviews on technically similar equipment and attending conferences to facilitate knowledge-based relationships with external colleagues.
Maintain regulatory knowledge of FDA requirements/guidelines regarding the development and approval process for NDA and IDE products through self-study tutorials professional research networks and FDA sanctioned conferences.
Share research approaches and best practices by presenting findings to local domestic and international colleagues through poster sessions and/or authorship/co-authorship of results.
Sustain membership(s) and affiliation(s) with clinical certifying bodies and maintain credentialing.
Identify additional needs for development of departmental methods or procedures and action accordingly.
Promote quality assurance safety environmental and infection control activities in accordance with established department policies and objectives. Participate in and/or perform external/internal system and data audits to ensure 21CFR departmental regulatory compliance. Maintain regulatory and compliance data. Coordinate and/or conduct annual awareness training in these areas. Other information: BASIC KNOWLEDGE:
Bachelor*s Degree or equivalent through relevant work experience is required.
Technical knowledge/aptitude and the demonstrated ability to develop investigational biologic and medical devices.
Proven leadership capabilities.
Excellent communication organizational problem solving and computer skills required.
EXPERIENCE:
Three years of research experience with progressively more responsibility required.
Experience in industry biologics and/or device development is highly desirable.
WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS:
While most duties are performed in an office environment risk of exposure to contagious or noxious elements is minimized by adherence to safety procedures and protocols. Contact with a laboratory environment with possible exposure to human and animal serum chemical reagents animal subjects and radioactive materials.
SUPERVISORY RESPONSIBILITY:
Mentoring/advisory responsibilities to inter-departmental clients and their staff. Brown University Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status. Brown University Health is a VEVRAA Federal Contractor. Location: Rhode Island Hospital USA:RI:Providence Work Type: Full Time Shift: Shift 1 Union: Non-Union Apply
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