Ref #: 25918

Employment type: Permanent - Full-Time

Location: United States - Nationwide

Posted: 10-Jan-2021

Description

DOCS is searching for Clinical Trial Assistants in the US for a home-based position. This will be for the Early Development group of a dedicated sponsor.

Responsibilities:

Partners with the LTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.

Supports the local study team in performing site feasibility and/or country feasibility.

Maintains site level protocol information in Trial Management Systems (e.g. CTMS).

In liaison with the LTM, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes.

Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval

Supports the LTM or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA.

Supports the SM/LTM in collecting and maintaining all documents throughout the trial and posttrial in both eTMF(i.e., IF/LAF sections) and paper files.

Distributes, collect, review, and track regulatory documents, agreements and training documentation.

Collects and tracks Financial Disclosure information at appropriate time points.

Qualifications:

* Skills set corresponding with preferentially 1-2 years relevant clinical trial experience or equivalent.
* Proficient in English language.
* Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint).
* Strong interpersonal and negotiating skills.
* Excellent organizational skills and the ability to collaborate and handle multiple priorities within a
matrix environment. Perform activities in a timely and accurate manner.

DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.

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