Documentation Assistant

**Role General Responsibilities**

The Documentation Specialist, under the supervision of the Documentation Coordinator, and in compliance with the applicable procedures, is mainly responsible for the study-related documentation archiving and preparation. Is responsible to train new team members on document management and archiving procedure.

**Some of what you will do**:

- Preparing and communicating to the staff concerned with the release of the Site List final version.
- Updating the Site List as applicable (data update, Site closeout) for the duration of the trial.
- Preparing the documents Trial Master Files, both blind and unblinded, in compliance with the Sponsor’s or OPIS’ SOP.
- Preparing and sending the Investigator’s Folder and any other study-specific folder.
- Updating and filing the tracking table for the Investigator’s Folders shipment.
- Verifying the formal correctness of the documents received from the Sponsor, identifying, and filing them.
- Providing the study team with operational support for the activities under your responsibility
- Checking the finalization of the reports produced by the Clinical Research Associate according to OPIS and Sponsor procedures.

**Requirements**:

- High School diploma
- Good English level
- Planning and organizational skills
- Communication skills
- Results-oriented
- Team-work oriented
- We offer a competitive salary with other benefits and opportunities to develop your professional career with an expanding and growing company._

We are looking forward to speaking with you

**Who we are**:

- Founded in 1998 in Italy and now operating at an international level, _**_OPIS_**_ is a full-service science-driven biotech-focused CRO providing premium trial management for multi-country clinical trials, including state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top-quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.) always contributing to our clients’ challenging achievements._

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