Clinical Research Associate

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.

Some of what you will do:

Identify investigator sites and participate in the feasibility process for new studies

Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e. ICH GCP

Perform visits remotely according to foreseen applicable procedures and time frames

Interact with the Trial Start-up team and support collecting the documents or information necessary for the ethical and administrative submission

Work closely with the sites to ensure that the planned recruitment targets are in line with the study plan/projections and motivate Investigators to achieve the targets

Check the correct submission and completion of informed consent forms

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

Verify that serious adverse events have been reported using a SAE form, according to OPIS and/or Sponsor procedures

Maintain all files and documentation pertaining to the studies and ensure that site documents are available for filing into TMF and correct archiving of files on study completion

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

Requirements:

Enthusiastic, knowledgeable and proactive

University degree in a scientific/life science field

At least 2 years of experience in managing and conducting clinical trials

In depth knowledge of ICH GCP principles

Able to carry out independently all the activities related to the monitoring of clinical trials

Good knowledge of Office Suite (Word, Excel, PowerPoint)

Organizational and problem-solving skills

Excellent written and verbal communication skills including good command of English language

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.

What we offer:

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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