Sr Research Administrator Clinical Trials

SUMMARY

Under the general supervision of the Administrative Manager Clinical Trials Office, ensures completion and performs a variety of functions related to the administrative aspects of research clinical trials. Works with a variety of clients, across all Brown University Health affiliates. 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. Instill Trust and Value Differences Patient and Community Focus and Collaborate

RESPONSIBILITIES

RESPONSIBILITIES

Performs a variety of functions related to the administrative, financial and regulatory aspects of research clinical trials. May lead special projects as needed, utilizing communication and organizational skills in achieving final goals. In collaboration with Principal Investigators (PIs) and Study Coordinators, reviews and approves administrative, financial and legal aspects of new drug and device clinical trials. Negotiates contract terms with pharmaceutical sponsors and assists PI/Study Coordinator with study budget negotiations. Reads and understands applicable sections of study protocol and informed consent, verifies adequate budget, reviews Medicare Coverage Analysis and various internally required documents. Ensures definition of scope of work and clarity of financial terms and billing provisions, performance requirements and indemnification. Amends sponsor agreements to meet Hospital standards and requirements. Interacts with Research Protection Office to ensure compliance with Clinical Trials Office (CTO) and Human Subjects Protection requirements. Conducts training sessions for investigators and other research staff in the areas of Medicare coverage analysis, EPIC usage, and completion of required documentation. Reviews internal research billing in EMR (EPIC) and resolves issues with patient billing as they relate to research. Conducts post‑award monitoring of expenses, revenue and activities; meets regularly with Principal Investigators/Study Coordinators to assess financial performance, program sustainability and growth, plans for future studies, personnel issues, and needs for additional assistance and training. Performs independently within department policies and practices. Refers specific complex problems to supervisor where clarification of departmental policies and procedures may be required. Supervisory responsibility: None.

QUALIFICATIONS

Basic Knowledge: A Baccalaureate Degree in business, health care, biological sciences or related field. Must have excellent computer skills in Microsoft Word, Excel, Access and Power Point. Comfortable in public speaking and training environments. EMR experience preferred. Experience: At least 5 years of progressively more responsible experience in the field of research administration (clinical trials, regulations, requirements), demonstrating knowledge of, and ability to interpret related requirements and regulations and to communicate effectively. Working Conditions and Physical Requirements: In office only; travel to and from various research sites in the Providence area. Walking on the hospital campuses to various locations. Normal office environment. Remote work considered. Independent Action: Performs independently within department policies and practices. Refers specific complex problems to supervisor where clarification of departmental policies and procedures may be required. Supervisory Responsibility: None.

COMPENSATION

Pay Range: $71,136.00-$117,353.60

EEO STATEMENT

Brown University Health is committed to providing equal employment opportunities and maintaining a work environment free from all forms of unlawful discrimination and harassment.

LOCATION & WORK DETAILS

Location: Rhode Island Hospital - 593 Eddy Street Providence, Rhode Island 02903 Work Type: 8:00am-4:30pm Work Shift: Day Daily Hours: 8 hours Driving Required: No #J-18808-Ljbffr Lifespan