Temporary Clinical Trial Associate (remote)
Website Corbus Pharmaceuticals
Company : Corbus Pharmaceuticals
Country: United States
Location : Park Place Industrial Park, Massachusetts
Post: Fri, 10 Sep 2021 04:59:37 GMT
Expires: Sun, 10 Oct 2021 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
The Temporary Clinical Trial Associate role is responsible for providing advanced support to the clinical team in the overall management of the planning, execution, and closeout of one or more clinical trials. The Clinical Trial Associate will have in-depth knowledge of the various stages and requirements of clinical trial processes and will function with more autonomy and provide higher level support to the Project Manager and study team. This role is accountable for ensuring assigned responsibilities are performed with a focus on quality execution and ensuring clinical trial participant safety, and protocol and ICH-GCP compliance.
Perform site management activities per assigned study (s) (e.g., ensuring study supply availability, protocol compliance, contribute to query management)
Establish and maintain sponsor and site relationships
Assist with and provide input into the preparation of site and study-related documents, tools, and templates (e.g. start-up forms, screening scripts, source documents, study logs)
Collect essential site and regulatory documents and review for quality and completeness
Mentor and train junior team members
Assist CPM with Vendor Management activities
Provide support and participate in clinical trial systems specification development and testing
Assist with reviews of study-specific essential regulatory document packets prior to site activations
Assist with the preparation and distribution of investigator site contracts and budgets
Update internal and external systems in a timely manner (CTMS) and assist with the maintenance of the Trial Master File.
Coordinate the ordering, shipping and tracking of trial materials (e.g. CRFs, lab supplies, drug supplies) as needed
Update internal and external systems in a timely manner (CTMS).
Ensure regulatory and other essential documents are filed in the Trial Master File
Provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussion with Project Manager and line manager
To apply for this job please visit www.resume-library.com.