Clinical Research Coordinator II

Summary : Clinical Research Coordinator 2 is a Part Time or Full Time Non-Exempt Position 

Education and Experience Requirements:

• Must be eligible to work in the U.S. and be a U.S. citizen
• More than 4 years of research experience; or
• 3+ years of research experience and a Bachelor Degree in a relevant area; or
• 3+ years of research experience and an LVN; or
• Greater than 1 year of research experience and a Masters Degree or Ph.D. in a relevant area; or

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 of Coordinator 2 (“CRC2”) works under light supervision of the Principal Investigator or more experienced coordinator. The Coordinator 2 is responsible for conducting procedures for one or more research studies. The CRC2 may supervise less-experienced Coordinators or Research Assistants. They will maintain the protection of human subjects while meeting the research goals of each project. A Coordinator 2 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 director HR and Operations, works closely with Team Leader

Duties : In addition to the knowledge of the duties of an Assistant Coordinator and a Research Coordinator 1, a CRC2 may have the following duties:

1. Assists in the design of research survey forms to capture required participant information
2. Interviews study participants and/or family members to gather research information

1. Reviews exclusion/inclusion criteria with the Principal Investigator or Senior Coordinator to ensure subject eligibility

1. Conducts interviews to confirm study eligibility and willingness to follow and complete study procedures and visits
2. May perform 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
3. Develops, coordinates and reviews research study procedures to ensure receipt, completeness and accuracy of study data
4. 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
5. May assist with the study budget and negotiation of participant payments
6. Monitors budget, prepares reimbursement requests, approves expenditures and reconciles study accounts
7. Prepares and submits information in the Case Report Form and submits a billing matrix for funding source and submits to DVARC
8. Prepares statistical reports, charts and graphs as required
9. Assists in preparation of annual reports for federal, state, and local agencies
10. Informs IRB of amendments to research studies
11. 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
12. Serves as primary liaison and prepares annual reports for federal, state, and/or local agencies.
13. Informs Institutional Review Board of amendments to research studies, and prepares protocols and detailed summaries in lay terms of any new research study
14. May provide full supervision to personnel of lower grades
15. May perform lower risk, less complicated procedures in studies, if directed by Principal Investigator
16. Must be able to do a study start up with the appropriate IRB and R&DC and safety committee.