Clinical Study Associate II
211 Mount Airy Rd Basking Ridge, NJ 07920 US
- Assisting planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager 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 trial management support to study teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance with Clinical Study Oversight Plan (CSOP).
- Reconcile the TMF document trackers generated by the CRO with the document archive. Bring issues with the reconciliation to the attention of the Study Manager and propose remediation plan.
- Distribute key study documents to the CRO and vendors as appropriate.
- 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).
- Support Fair Market Value process in evaluating study budgets
- Under supervision, review and document CRO-generated reports, such as site monitoring trip reports and protocol deviation reports and elevate issues to the attention of the supervisor.
- Compile and maintain a monitoring review spreadsheet.
- Ensure the Trial Master Files are inspection ready.
- 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 your supervisor.
- Create/maintain spreadsheets to track other items as needed, (e.g. Vendor invoices).
- Analyze study site metrics reports to identify potential areas of concern and bring to supervisors attention.
- Demonstrates knowledge of complex processes related to clinical studies, regulatory issues, CRO operations, and compliance practices
- Interacts appropriately with internal and external stakeholders (e.g., CROs and other team members).
- Demonstrates foundational knowledge and application of complex compliance practices
- Effectively manages information, data, related analyses, forms and reports
- Supports and effectively multi-tasks different and complex assignments and responsibilities.
- Identifies and resolves problems when able to, escalates issues appropriately
- Familiarity with medical terminology. Working skills in computer applications, such as Microsoft Word, Excel, PowerPoint, and Outlook. Basic oral and written communication skills.
- A Bachelor’s degree (preferred in Life Sciences) with relevant clinical development experience is acceptable.
- Experience considered relevant includes 3 years of clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). CRA experience is preferred.
- Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.
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