Unblinded Clinical Research Associate

Job Overview:

Are you ready to discover your next career at Covance?

We are currently looking for talented  Clinical Research Associates to join our  unblinded team in Belgium. You would be working within our Flexible Solutions department dedicated to one sponsor/client.

A career at Covance provides our employees the unique chance to create an immediate impact and difference in our patient’s lives. Joining Covance Flexible Solutions (FSPx) will offer a rewarding career, a chance to work in an energetic & team oriented work place, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning.

Would you like to work for one of the best known big pharma companies? Our sponsor is a global mid sized pharma company with high working standards. Are you passionate about growing in Clinical Field? We are proud to have an excellent team of the best professionals on the market and are looking for people who are ready to show true performance and interest in Clinical Trials. Do you like responsibilities and challenges? As a Clinical Research Associate you will lead all aspects of study site monitoring according to Covance SOP, ICH guidelines and GCP. You will take part in pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.

 Our sponsor invests heavily in training and crafts modern system of Clinical Trials so if you are passionate about working with a phenomenal team and expand your horizons feel free to reach us.

Responsibilities Include

All details of site management as prescribed in the project plansRecruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasksNegotiation of study budgets with potential investigators and cooperation with Covance legal department with statements of agreementsSerious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systemsEducation/Qualifications:

University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)

Experience:Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH GuidelinesExcellent understanding of Serious Adverse Event (SAE) reportingAbility to resolve project-related problems and prioritize workload for self and teamYou have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).

Covance is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.