The VA Cooperative Studies Program Coordinating Center (CSPCC) at Hines VA is looking to hire full time Research Project Managers to provide support and coordination for large multicenter clinical trials. For more information on the VA Cooperative Studies Program - https://www.research.va.gov/programs/csp/ . Hines CSPCC is located in the near western suburbs of Chicago adjacent to Loyola Medical Center. Must be a US Citizen to apply for this job.
Interested applicants should forward their resumes to me, Joyce Gilroy, Associate Director Administrative Operations, at joyce.gilroy@va.gov. A description of the position follows. If you have any questions, please contact Ms. Gilroy at 708-202-5850.
Research Project Manager, Hines CSPCC The incumbent will be the principal figure in providing administrative support and coordination for studies that vary in length of time, number of participating sites and number of research subjects for the Hines Cooperative Studies Program Coordinating Center (CSPCC).
Principal Duties and Responsibilities
- Participates in the planning of the proposed study and development of the research proposal. Coordinates interaction and cooperation between the research study site investigators, site coordinators, the CSPCC, the Study Chairpersons, the Albuquerque Research Pharmacy (CSPCRPCC), any outside funding agencies and any technical support facilities required for the studies.
- Serves as a resource person regarding details of the study protocol and facilitates training for study personnel to ensure they follow the study protocol and data collection procedures. Assists in development and distribution of the study operations manual. Drafts study correspondence and ensures that appropriate tasks, correspondence and study documentation are completed in the sequence established by CSP.
- Prepares agendas and materials for study meetings in consultation with study team. Participates in study conference calls and attends study meetings. Serves as a recorder of minutes and prepares draft reports of meetings, when needed.
- Serves as primary liaison with all participating study sites in securing both initial and yearly approvals from Institutional Review Board of record and Research & Development Committees.
- Coordinates the Human Rights Committee (HRC) site visits and ensures that all required documentation for conducting these visits are prepared and distributed. Maintains documentation of Study Group, Executive Committee, Data Monitoring Committee and HRC reports.
- Reviews all budget requests for accuracy and evaluates special requests for budgetary increases and makes recommendations. Monitors expenditures of study funds to ensure the study is within budget. Prepares budget summary and reports as required. Recommends and oversees the purchase of study equipment, patient incentives and other items needed for the studies.
- Receives and manages the distribution of the site monitoring reports and site audit responses to sites, CSP offices, Study Chairpersons and any necessary outside agencies.
- Assists in the quality assurance process for assigned studies and responsible for maintenance of the study Central Study File per GCP requirements. Assists site personnel in maintaining site documentation in compliance with GCP and VA requirements
Other Significant Factors
Incumbent must be able to work independently and plan, coordinate and organize work in a situation where numerous "top priority" demands are involved. Must be able to act independently and be prepared to deal with a myriad of complex problems. The major responsibility of the incumbent is to oversee the day-to-day function of a multi-site study and to independently deal with many of the difficulties that arise.
The incumbent devises and modifies methods and procedures that effect the accomplishment of the mission of this study. Identifies and resolves various problems and situations that affect the orderly and efficient flow of data acquisition and administrative transactions. This work directly affects the quality, quantity, and accuracy of the study/studies.
This work requires knowledge and skill in the application of related laws, regulations, policies, precedents, methods and project management of clinical trials. Communication, organization and interpersonal skills are of the utmost importance in daily activities as incumbent will coordinate interaction and cooperation between the study site investigators, the CSPCC, the study chairman and office staff, the CSP Albuquerque Research Pharmacy, VA CSP Central Office and the VA Office of Research & Development. Must also have excellent verbal and writing skills.
Baccalaureate degree in a science, e.g., biology, chemistry, psychology, public health or health related field is minimum requirement but advanced degree is preferred. The advanced degree can be in another field such as project management if the baccalaureate degree fulfills the minimum requirement.
Joyce Gilroy
Associate Director for Administrative Operations,
Cooperative Studies Program Coordinating Center
Hines VA Hospital, CSPCC (151K)
5000 South 5th Avenue, Building 1, Room B-237
Hines, Illinois 60141-3030
e-mail: Joyce.Gilroy@va.gov phone: 708-202-5850 fax: 708-202-2116
