Covance Clinical Research Associate II, Belgium in Brussels, Belgium
We are currently looking for talented Clinical Research Associates to join our team in Belgium. You would be working within our Flexible Solutions department dedicated to one sponsor/client.
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.
You will become a part of our team who is always ready to help. We offer a home based position so you will not spend time on unnecessary travels but at the same time we highlight a true live relationship between colleagues. You will have a possibility to devote all your professional skills and knowledge into monitoring investigational sites as we organize our work environment and responsibilities with high standards.
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.
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
Responsible for all aspects of site management as prescribed in the project plans
General On-Site Monitoring Responsibilities
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
Monitor data for missing or implausible data
Ensure the resources of the Client are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Client and Covance travel policy. Travel, including air travel, may be required and is an essential function of the job.
Prepare accurate and timely trip reports
Responsible for all aspects of registry management as prescribed in the project plans
Undertake feasibility work when requested
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Independently perform CRF review; query generation and resolution against established data review guidelines on Client data management systems as assigned by management
Assist with training, of new employees, e.g. co-monitoring
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
Perform other duties as assigned by management
Education / Qualifications
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
Excellent understanding of Serious Adverse Event (SAE) reporting
Ability to resolve project-related problems and prioritize workload for self and team
You have previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).
Job Number 2018-20476
Job Category Clinical Research Associate
Position Type Full-Time
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.