Research Associate

3 weeks ago

England, United Kingdom OPIS Full time

As a  Clinical Research Associate (CRA) you are an essential part of the clinical operations team responsible for coordinating and overseeing the execution of studies and clinical trial according to the study protocol, ICH-GCP, applicable regulations, guidelines and sponsor requirements.
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e. Perform visits remotely according to foreseen applicable procedures and timeframes
Manage the progress of assigned studies by tracking regulatory submissions and approvals, case report form (CRF) completion and submission, and data query generation and resolution
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation
University degree in a scientific/life science field
At least 2 years of experience in managing and conducting clinical trials
Able to carry out independently all the activities related to the monitoring of clinical trials
Good knowledge of Office Suite (Word, Excel, PowerPoint)
Excellent written and verbal communication skills including good command of English language
No restrictions to travel onsite
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.) We offer a competitive salary with other benefits/bonuses and opportunity to develop your professional career with an expanding and growing company.
Please read the information notice on the processing of personal data in the candidates information section of our company website.

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