Clinical Trials Research Coordinator

Brown Medicine•Cranston, RI

1d•$64,480 - $106,413•Onsite

About The Position

SUMMARY: Reporting to the Director of Clinical Research, and in accordance with established departmental policies and procedures, is responsible for representing the Department of Emergency Medicine with regard to the implementation, operations and auditing of sponsored clinical research projects. Responsibilities include Clinical Research Proposal creation/submissions, IRB regulatory package creation/submissions, management of regulatory endpoint audits, maintain data management knowledge and expertise, maintain oversight of the day-to-day project management of assigned projects/budgets/staff and the mentoring/development of clinical research colleagues/clients. Brown University Health employees are expected to successfully role model the organization's values of Compassion, Accountability, Respect, and Excellence as these values guide our everyday actions with patients, customers and one another. In addition to our values, all employees are expected to demonstrate the core Success Factors which tell us how we work together and how we get things done. The core Success Factors include: Instill Trust and Value Differences Patient and Community Focus and Collaborate 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 externalnternal 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.

Requirements

Bachelor’s Degree or equivalent through relevant work experience is required.
Technical knowledgeptitude and the demonstrated ability to develop investigational biologic and medical devices.
Proven leadership capabilities.
Excellent communication, organizational, problem solving and computer skills required.
Three years of research experience with progressively more responsibility required.

Nice To Haves

Experience in industry biologics and/or device development is highly desirable.

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 externalnternal 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.