Tech Observer | Clinical Study Associate | warren, mi

3 days ago


warren, United States Tech Observer Full time

Duties:

Assist in 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.


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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