The VA STARPORT trial seeks a National Coordinator
The Veterans Affairs seamless phase II/III randomized trial of STAndard systemic theRapy with or without PET-directed local therapy for OligoRecurrenT prostate cancer (VA STARPORT) is seeking a Full-time National Coordinator to join our study team at Hines VA hospital.
The National Coordinator will collaborate with the Hines CSP Coordinating Center team as part of the Study Chair’s Office to lead the daily operations of this 16-site clinical trial enrolling Veterans with recurrent prostate cancer that will determine the role of metastasis-directed therapy as part of the standard of care.
This is a critical leadership role and we seek a candidate with the enthusiasm, clinical expertise, communication skills, and organizational skills to be this central pillar for the successful conduct of the study.
Below are some of the specific responsibilities this person will assume in the Study team:
Role of the National Study Coordinator:
§ Monitors site recruitment, and determines methods for increasing recruitment (advertisements, etc.)
§ Facilitates communication between study sites, as well as communication with the Hines CSP coordinating center
§ Gives the site guidance on a backup plan for when a site coordinator / site is on extended leave
§ Works in close contact with the Study Chair and the Hines CSP Coordinating Center in all aspects of the design/conduct/reporting of the study
§ Serves as primary liaison to the VA Central IRB. Submits applications, continuing reviews, amendments and all other documentation for Chair’s Office and facilitates all study sites’ submissions to Central and Local IRBs, as well as Research & Development committees.
§ Trains study site personnel on the Operations Manual and protocol with respect to clinical issues [study design, eligibility criteria, informed consent process] and sets up online trainings for those who cannot attend annual or kickoff meetings
§ Develops the Study Operation Manual with the National Project Team
§ Works on design/development/testing/revision of the data collection forms (case report forms and source documents)
§ Tests study electronic data capture system prior to patient intake
§ Assists Study Chair in development of PowerPoint presentation(s) for the study kickoff meeting, monthly and annual meetings, and on-going trainings
§ Answers/triages clinical study questions from site coordinators and site investigators to serve as the expert in the clinical aspects of the study conduct (together with the Study Chair)
§ Reviews/completes/notifies/files all enrollment waivers with the study chair
§ Maintains documentation of study-related conversations (telephone log, etc.) between the Study Chair’s Office and study team members (i.e., patient care, advice on how to conduct visits, enrollment waivers, etc.).
§ incorporates Good Clinical Practice (GCP) in maintaining study files and in all aspects of study conduct.
§ Obtains Study Chair’s Office IRB/R&D approval for the study protocol as necessary
§ Schedules Executive Committee calls/meetings according to protocol schedule or per request of the Study Chair or coordinating center
§ Takes, writes and distributes Executive Committee minutes
§ Schedules date, time, and location, sets the agenda, and takes minutes for the annual study meetings
§ Schedules date, time, and location, sets the agenda, and takes minutes for site coordinator conference calls, site investigator conference calls, coordinating center conference calls
§ Collaborates with Project Manager to develop site coordinator position description for site investigators’ use in hiring process
§ Manages site coordinator & site investigator contact and mailing information. (including mobile phone, email, and pager numbers for site investigators)
§ Performs site monitoring to ensure protocol, GCP, and VA regulations compliance.
§ Maintains confidentiality and utilizes appropriate channels of communication when sharing information between sites and the Hines CSP coordinating center.
§ Coordinates study bulletin/newsletter to be distributed to site staff at set time interval to update sites on study issues, frequently asked questions, recruitment and to recognize good work.
§ Gives regulatory guidance and is the 1st point of contact for GCP for the study sites.
§ Advising on development of manuscripts and scientific writing, with the potential for co-authorship.
§ Manages selection information regarding back-up/expansion sites and assists with site selection.
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 national 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 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 Hines CSP coordinating center, the Study Chair and the VA Office of Research & Development. Must also have excellent verbal and writing skills.
Further Information:
Hines VA hospital is in the near western suburbs of Chicago adjacent to Loyola Medical Center.
A licensed healthcare provider (RN, NP, PA, etc.) is a minimum requirement. Experience in clinical oncology patient care and clinical trial research are preferred.
Must be a U.S. Citizen to apply.
For more information on Edward Hines, Jr. VA Hospital –
For more information on VA Research & Development –
For more information on the VA Cooperative Studies Program –
https://www.research.va.gov/programs/csp/
Please contact Katherine Blair at katherine.blair@luhs.org to apply.
