Education and Experience Requirements:
SoCRA or ACRP Certification : Highly desirable and counts as one year of experience
Software Requirements : Experience with Microsoft Office and research database products
Responsibilities : The position works under light supervision of the Principal Investigator or more experienced coordinator. The Coordinator is responsible for conducting procedures for one or more research studies. The Coordinator may supervise less-experienced Coordinators or Research Assistants. They will maintain the protection of human subjects while meeting the research goals of each project. Will consistently exhibit behavior and communication skills that demonstrate DVARC’s commitment to superior customer service and dedication to the care of our veterans.
Supervisors : VANTHCS Principal Investigator, DVARC Coordinator Manager and/or Senior Coordinators
Duties :
3. Reviews exclusion/inclusion criteria with the Principal Investigator or Senior Coordinator to ensure subject eligibility
4. Conducts interviews to confirm study eligibility and willingness to follow and complete study procedures and visits
5. Performs consent process with patients, ensuring inclusion and exclusion criteria are met, taking responsibility for all aspects of research completeness, enrollment notes, administrative duties and data entry
6. Develops, coordinates and reviews research study procedures to ensure receipt, completeness and accuracy of study data
7. Coordinates, with the assistance of higher grade staff, all regulatory requirements such as preparing safety reports, adverse event paperwork, FDA compliance, sponsor monitoring and logs, laboratory standards, and maintenance of databases related to regulatory requirements
8. May assist with the study budget and negotiation of participant payments
9. Monitors budget, prepares reimbursement requests, approves expenditures and reconciles study accounts
10. Prepares and submits information in the Case Report Form and submits a billing matrix for funding source and submits to DVARC
11. Prepares statistical reports, charts and graphs as required
12. Assists in preparation of annual reports for federal, state, and local agencies
13. Informs IRB of amendments to research studies
14. Coordinates collection and data management of national research studies from multiple projects by interacting with internal and external research data managers, patients, and physicians for coordination of tissue samples, lab data and protocols, and other statistical information concerning research study subjects
16. Serves as primary liaison and prepares annual reports for federal, state, and/or local agencies.
17. Informs Institutional Review Board of amendments to research studies, and prepares protocols and detailed summaries in lay terms of any new research study
18. May provide full supervision to personnel of lower grades
19. May perform lower risk, less complicated procedures in studies, if directed by Principal Investigator