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Temporary Clinical Trial Associate (remote)

  • Contract
  • Anywhere

Website Corbus Pharmaceuticals

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 ——————————

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.

PRIMARY RESPONSIBILITIES:

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

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