Clinical Trial Associate (Clinical)

Job Description

The Clinical Trial Associate provides support for Phase 1-4 clinical trials.

Essential Functions Include:

· Performs general administrative tasks to support team members with clinical trial execution

· Assist in the preparation, handling, filing, and archiving of clinical documentation and reports according to SOPs and study requirements (eg. eCRF, protocol deviations, study payments, etc.)

· Collect, disseminate, and/or track study regulatory documentation as assigned

· Assists with eTMF activities including but not limited to filling and quality oversight as assigned

· Facilitate internal project communication, correspondence, and associated clinical information while providing timely and accurate study updates that will ensure completion of key study activities

· Manage and track clinical and non clinical supplies, including purchase as shipment as assigned

o Provide logistical support to one or more clinical trials including, but not limited to

o Placing and tracking study drug orders including receipt and filing of site receipt and temperature control documentation

o Managing clinical supply orders and inventory to support study drug administration

o Centralize and optimize kit production processes as assigned

o Overseeing clinical trial supplies related to biospecimen kit creation, kit distribution, sample collection, processing, shipment, and storage as, well as maintenance of associated tracking information

Qualifications

Qualified candidates must have:

• · Bachelor’s degree or equivalent is required (scientific or healthcare discipline preferred).

  · 2+ years of experience working on clinical studies in the biopharma, diagnostics, and/or medical device field

  · Proficiency in web-based systems and project management applications (eg. Microsoft Office, SharePoint, etc.)

  · Familiar with the Trial Master File structure and organizations

  · Familiar with the biosample management and sample processing including but not limited to biobanking as well as the kit production

  · Familiar with IVRS and EDC systems

  · Being able to follow and comply with assigned SOPs

  · Knowledge of ICH-GCP and applicable regulatory agency regulations

• · Must be able to prioritize and manage a large volume of work and show attention to details

• · Effective communication and interpersonal skills with ability to partner with cross functional internal and external stakeholders

  · Demonstrated analytical skills and ability to identify problems and propose solutions

Additional Information

All candidates must be legally eligible to work in the United States.

We are an equal opportunity employer. M/F/D/V

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.