Title of Position: Clinical Study Associate I
Location: Road Basking Ridge, NJ 07920
# of position openings: 1
Contract Length: 12 months
Assist in planning and execution of clinical studies, under the close supervision of a Senior Manager (or above) within Clinical Operations, in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical administrative support to study teams and on interacting with the Contract Research Organizations (CROs) and other vendors conducting the study to help monitor compliance with Daiichi Sankyo (DS) Quality Oversight measures. Support and assist the transmittal of trial and site level document to the DS Document Control Center (DCC) in support of the Trial master File (TMF). Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the supervisor. Provide clinical administrative support to the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings. Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov). Works with Insurance Brokers to obtain study site Insurance Under the guidance of the supervisor, analyze site metrics reports to identify potential areas of concern and bring to supervisor’s attention. Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to the supervisor. Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices).
Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO), and Contract Research Organization (CRO). Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook. Basic oral and written communication skills.
An associate degree or assoc nursing degree/diploma with relevant clinical development experience is acceptable. Bachelors degree or higher preferred.
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