Sr. Clinical Trial Associate
4 weeks ago
A Sr. Clinical Trial Associate position in Cambridge or Bedford, MA is now available through Adecco Healthcare and Life Science. In this role, you will be responsible for administering, maintaining, and coordinating the logistical aspects of clinical trials. The Sr. CTA will provide support during clinical study planning and execution, including management of internal clinical study team meetings. The Sr. CTA will also be responsible for providing support and oversight of vendor management activities.
The work hours are Monday-Friday from 8:00am-5:00pm. This is a minimum 6-month potential temp-hire role starting in August 2024. There is no option to work remotely - 100% onsite and only local candidates will be considered.
Key Responsibilities:
Coordinates and tracks the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visit reports, etc.
Supports maintenance of inspection-ready Trial Master File (TMF) according to ICH-GCP and company SOPs including performing quality checks on the study TMF with oversight of study lead.
Proactively supports the oversight of clinical studies, interacting with CROs and study vendors to ensure goals and objectives are accomplished within projected timeframes and budget requirements.
Track development, review, finalization, and delivery of high-quality key clinical study documents, including but not limited to clinical protocol and amendments, informed consent forms, Investigator Brochure, and other required regulatory submission documents.
Supports clinical trials to help maintain a continuous state of internal and external audit readiness.
Assist in the development of study-related documents, training materials, management of clinical study material, and presentations.
Review of meeting minutes and follow-up on action items.
Follow-up with day-to-day operational activities with assigned vendors.
Support and maintain strong collaborative relationships with external vendors and CROs as needed.
Ensure documentation is completed in accordance with GCP regulatory requirements and consistent with study protocols.
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Sr. Clinical Research Associate
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Cambridge, United States Adecco Full timeA Sr. Clinical Trial Associate position in Cambridge or Bedford, MA is now available through Adecco Healthcare and Life Science. In this role, you will be responsible for administering, maintaining, and coordinating the logistical aspects of clinical trials. The Sr. CTA will provide support during clinical study planning and execution, including management...
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Cambridge, United States Moderna, Inc. Full timeThe RoleThe Senior Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs. The position may report to the Sr. Director,...
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Cambridge, United States Moderna, Inc. Full timeThe Role:The Senior Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs.The position reports to the Director,...
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Cambridge, United States Moderna, Inc. Full timeThe Role:The Sr. Clinical Trial Manager (Sr. CTM) provides clinical trial oversight to the assigned clinical trial(s), which may be complex or high priority, and ensures deliverables are met in terms of quality, compliance and timing. Strong vendor management is critical for this role. external vendors and CROs.The position may report to the Director,...
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