Research Program Admin

Summary:

Reporting to the Service Line Director of Urology plans coordinates develops monitors and coordinates the departmental research activities for the Department of Urology at The Miriam Hospital Rhode Island Hospital and other sites across the service line as needed.

Administers programs and day-to-day research operations including grant management grant preparation financial activities regulatory affairs program and protocol development quality assurance and data management. Establishes systems and procedures for smooth coordination of the research activities. In addition this position will be overseeing research regulatory requirements which may include monitor visit coordination and documentation as well as resolving all regulatory IRB requirements.

Responsibilities:

PRINCIPAL DUTIES AND RESPONSIBILITIES:

Coordinates research efforts in the recruitment of new faculty and staff. This may include advising new faculty on transfer procedures including relocation of equipment and financial arrangements. Is responsible for coordination of facility management staff new recruits and support departments in the establishment and construction of space for the recruitment program.

The Research Program Administrator ensures compliance in the regulatory aspects of the research activities.

Oversees the operations of the clinical research program within the department and with department research coordinators and administrators to ensure successful implementation of the research program. Monitors the research through internal audits and by working with the resources of the Office of Research Administration (ORA) to ensure adherence to protocols and procedures sufficient productivity efficiency and alignment with other relevant programs. Prepares the annual budget for the Program(s) utilizing external and internal resources.

Develops and maintains accurate fiscal reports on status of research activities and distributes to research investigators on a regular basis. Assists in timely completion of institutional and funding agency reports. Forecasts and reviews financial status of grant monies with investigators as necessary. Ensures timely submission of information necessary to comply with hospital State Federal and funding institutions* regulations. Meets on a regular basis with members of the Office of Research Administration Research Finance and departmental management as needed.

Maintains and updates all profile information (including medical licensures lab accreditations and CVs) IRB status consent form versions and all safety information

Provides functional guidance in regulatory functions including initial reviews updates revisions consents and all changes continuing reviews closures terminations

Reports monitors distributes and maintains files for all safety information including Investigational Drug Brochures IND safety reports and all SAEs (Serious Adverse Events)

Identifies and pursue grants contracts subawards and other opportunities that ae beneficial to the Urology Department both clinically and financially.

Serves as a liaison between Brown University Health Urology & The Warren Alpert Medical School of Brown University for research-based activities and correspondence.

Maintains and updates all profile information (including medical licensures lab accreditations and CVs) IRB status consent form versions and all safety information

Prepares all regulatory documentation packets and creates all FDA 1572 forms and FDA 1571 forms for IND filings. Ensures all necessary forms are submitted to Sponsor Company to activate protocols.

Distributes and tracks financial disclosure forms protocol signature pages and FDA 1572 forms to obtain local investigator signatures

Tracks expirations and retrieves current documentation for medical licensures CVs and laboratory accreditations.

Disseminates regulatory documents including protocols amendments consent forms SAE forms to all appropriate personnel

Distributes IRB documentation and post IRB meeting information to study sponsors research and clinical staff.

Consults with and/or provides advice regarding regulatory documents and/or processes related to clinical trials conduct

Develops and maintains complete records of protocol approval status and annual reviews. Coordinates all required submissions related to protocol physicians and procedures to the Office of Research Administration. Monitors all studies in area of responsibility to ensure adherence to Good Clinical Practice (GCP) guidelines and federal regulations including documentation and consenting procedures.

Coordinates archiving of study documents with research team

Serves as liaison between outreach sites and the office on issues related to regulatory documents

Ensures appropriate use of tracking mechanisms for regulatory documentation and retrieval

Notifies study and site coordinators of site readiness for study initiation

Provides functional guidance and trains data managers in regulatory functions including initial reviews updates revisions consents and all changes continuing reviews closures terminations

Assists the Service Line Director with research administrative activities of Urology department where there are multi-site research programs including coordinating and overseeing human resource and payroll issues. Interacts with research administration and human resource department regarding new positions recruiting job changes salary reviews and other related policies and procedures to assist PI*s.

Monitors time sheets and employee change forms for hourly and salaried research oriented personnel within department of neurosurgery. Assures that funds are available and notifies PI*s and Service Line Director when adjustments become necessary. Coordinates with Administrative Director and research administration on problem issues as appropriate.

Assists Principal Investigator(s) with development design and data management specifics of new studies and forms; may assist with tabulating and reviewing data results for publication and reporting. Also assists in developing protocols intervention plans and subject recruitment.

Establishes and supervises all data collections and quality assurance procedures to assure conformance with protocol requirements standards and timeliness of research base.

Assists research investigators in budgeting and managing financial accounts effectively within the guidelines and policies established by the Hospital as well as sponsoring agencies. Resolves problems as required.

Develops and implements the department*s clinical research operating procedures consistent with personnel policies and Lifespan.

Coordinates audits and on-site visits by the funding agencies pharmaceutical companies foundations and research bases.

Acts as a liaison to the hospital; serves on community and other various committees.

Maintains and enhances professional expertise through appropriate educational opportunities and literature.

Maintains communications with review committees to learn of any new requirements and to help ensure compliance with current regulations.

Leads & coordinates all aspects of Departmental iCure meetings

Prepares/provides reports and documents as requested by the Chief of Urology or Service Line Director with whom meetings are held on regular basis.

As appropriate may provide general administrative support for the research investigators who are in the Department of Urology

Other related duties and projects as necessary.

Other information:

BASIC KNOWLEDGE:

Master*s Degree in public or hospital administration or biomedical sciences is required.

EXPERIENCE:

The incumbent will have at least six years experience in the required field with three or more progressively more years of responsible experience depending on the size and complexity of the program(s). Experience should demonstrate leadership and training skills knowledge of research regulations and the ability to work with collaborative groups.

Excellent verbal and written skills are essential. The ability to interact with persons from diverse backgrounds such as MD*s PhD*s research and administrative staff.

Thorough knowledge of microcomputers peripheral equipment and networks. Thorough knowledge of software such as Microsoft Word Excel Access and Windows. Ability to learn specific research access program.

Strong-self-starter interpersonal skills and influence are necessary

Team-oriented with excellent oral and written communication skills

Strong problem-solving skills

WORK ENVIRONMENT AND PHYSICAL REQUIREMENTS:

While duties are performed in an office environment incumbent is exposed to the patient care environment.

INDEPENDENT ACTION:

Performs independently within the department*s policies and practices. Refers specific complex problems to the supervisor(s) when clarification of the departmental policies and procedures are required.

This position requires a quick-thinker who can make basic and sometimes complex decisions pertaining to the completion and transmission of required regulatory documentation to internal departments as well as external agencies including but not limited to Cooperative Groups University agencies local and federal agencies. The candidate should be able to answer protocol regulatory inquiries from researchers and physicians as well as from the local Institutional Review Board. This person should also be able to work with outside monitors and work independently to obtain all necessary paperwork toward a successful monitoring visit. He/she should be able answer inquiries related to regulatory issues and if not known communicate with the correct person to determine the answer.

SUPERVISORY RESPONSIBILITY:

Supervisory responsibilities for up to 15 FTEs.

Brown University Health is an Equal Opportunity / Affirmative Action 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: The Miriam Hospital USA:RI:Providence

Work Type: Full Time

Shift: Shift 1

Union: Non-Union