Documentation Assistant

Overview

The Documentation Assistant, under the supervision of the Documentation Coordinator, is mainly responsible for study-related documentation archiving and preparation. The role includes training new team members on document management and archiving procedures.

Responsibilities

• Preparing and communicating to the staff concerned 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
• Please note that this position offers a one year contract.
• We offer a competitive salary with other benefits and opportunities to develop your professional career with an expanding and growing company.

About Us

OPIS is an International CRO with 25 years of experience conducting Phase I-IV, non-interventional, and medical device studies internationally. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects. OPIS's extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, and offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services such as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.

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