Clinincal Research Operations Coordinator
Company: RightPro Staffing
Posted on: May 7, 2022
Clinical Research Regulatory and Operations Coordinator
- Reports to the VP, Research and Innovation. Collaborates with the
research leadership, staff, and investigators in the coordination
of regulatory and operational aspects of investigator-initiated
research (IIR) studies.
- Responsibilities include; all regulatory submissions, billing and
invoicing, tracking Investigator-Initiated Research tracking
databases, tracking patient screening and recruitment, protocol
implementation, and data tracking.
- Manages submissions to the Institutional Review Board (IRB)
Performs additional non-clinical clinical research coordinator
duties (e.g. data collection, obtaining informed consent) as
- Coordinates IIR studies in all therapeutic departments with the
exception of the Cancer Center.
- Collect, review, and submit all documents required for initiating
IIR Coordinate study start-up documentation requests in an
organized package and submit to the IRB.
- Compile documents, including but not limited to, CVs, licenses,
certificates, training logs, and financial disclosures, lab
certifications (CLIA and CAP) for all study staff to be involved in
IIR. Ensure all documentation for active studies remains current
and filed appropriately.
- Support the daily operations of IIR by providing efficient
administrative services including maintaining any IIR databases and
study tracking spreadsheets and generation of departmental minutes
- For all studies requiring continuing review, ensure that all
paperwork is submitted to the IRB in a timely fashion.
- Handle invoicing, billing, and tracking payments and revenue for
internal and external stakeholders.
- Attend onsite study initiation meetings with study teams.
- Prepare regulatory documents, Safety reports, and Serious Adverse
event submissions and participates in internal and external
regulatory quality assurance reviews and audits.
- Serve as a research coordinator for departmental IIR research
projects as required.
- Ensures all documents remain up to date.
- Bachelor of Sciences
- Some healthcare ideal clinical research, administrative or
- Strong analytical, communication, and organizational skills
- Clinical Research Coordinator certification a plus
Keywords: RightPro Staffing, Hartford , Clinincal Research Operations Coordinator, Other , Hartford, Connecticut
Didn't find what you're looking for? Search again!