Responsibilities will include :
Supporting the project team to ensure optimal management of all documents with logistical and administrative tasks related to trial start-
up, execution and closing of clinical trials.
Performing regulatory document review and approval, including site specific Informed Consents.
Ensuring trial related activities are in compliance with GCO SOPs, policies and local regulatory requirements.
Maintaining site level protocol information in Trial Management Systems (e.g. CTMS)
Working with investigational site staff to ensure accurate / complete regulatory documents are in place to expedite IEC / IRB or Health Authority (if applicable) approval process.
Distributing, collecting, reviewing, tracking and archiving documents, agreements and training documentation.
To be suitable for this position you must be able to show evidence of
Experience in clinical research area
Intermediate English and fluent Russian
Good communication skills and eager to learn
Open to do administrative work (e.g. filing, review and create trackers) and system updates etc
We offer competitive salary and benefits package which includes : life and health insurance, additional vacation days, lunch allowance.
Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.