This position assists in the coordination of clinical research projects starting with the evaluation of feasibility and safety of the study. The position will participate actively in the research projects of a diverse group of researchers in community.
ResponsibilitiesManage studies per FDA, GCP and ICH regulations following the guidelines that apply.
Maintain training certificates required for research investigator and their staff listed on the delegation of duties log or approved IRB staff.
Acquire current CV’s and licenses for all study staff for files, regulatory binders and forwarding to sponsors.
Responsible for IRB preparation, submission, annual reporting, adverse reporting/deviations as required and amendment submissions as needed to keep all regulatory documents current and approved. Ensuring PI signature both electronic and paper.
Develop informed consents, obtain informed consent and assure that anyone listed on the study delegated to obtain consent is doing so per regulations and consent is documented appropriately and maintained per SOP for review.
Develop source documents, complete as needed and review and document where and how source was obtained.
Review clinical patient appointment schedules for possible eligibility of participants in clinical studies.
Evaluates potential volunteers by obtaining in depth medical history as related to study inclusion/exclusion criteria.
Explain study requirements to volunteers, obtaining informed consents prior to study initiation.
Responsible for data entry and reconciliation of queries. Assurance that data is ALCOA-C compliant.
(Attributable, legible, contemporaneous, accurate and complete)
Collaborates with faculty and clinical staff to coordinate scheduling of events per the protocol.
Collaborates with the P.I. to review data on an ongoing process to ensure adherence to the protocol activities and report any changes as needed to the sponsor or other regulatory agencies as needed/required.
Responsible for prompt reporting of any serious adverse events to the PI, sponsor and any other regulatory agencies as required.
Maintains all regulatory documentation, accurate patient logs and study flow sheets. Conducts case file audits with study monitors on an ongoing basis.
Sterilizes equipment and supplies. Inventories supplies monthly. Tracking expiration dates and requisitioning for replacement/s.
Facilitate the collection of biological samples, including drawing blood, prepare store or ship as per central laboratory guidelines. Prepares samples for shipping per IATA/shipping of biologic sample guidelines.
Performs other duties as assigned.
QualificationsBachelor’s degree (in science related field preferred). Previous clinical research experience is highly preferred.
Location : Location US-VA-Norfolk