Covance Clin Res Assoc II in Belgium
We are currently looking for talented Clinical Research Associates II to our team in Belgium.
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.
All details of site management as prescribed in the project plans
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks
Negotiation of study budgets with potential investigators and cooperation with Covance legal department with statements of agreements
Serious 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 systems
Conducts site monitoring of clinical research studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
Provide clinical support for projects according to Covance Standard Operating Procedures, ICH Guidelines and GCP
Site management responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP
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, with or without guidance; and other duties, as assigned
Responsible for aspects of registry 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 are spent wisely by performing theguidelines, including managing travel expenses in an economical fashion according to Covance travel policy
required monitoring tasks in an efficient manner, according to SOPs and established
Travel, including air travel, may be required and is an essential function of the job.
Prepare accurate and timely trip reports
Perform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on data management systems, as assigned by management
Assist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site management
Provide coverage for clinical contact telephone lines, as required
Update, track and maintain study-specific trial management tools/systems
Generate and track drug shipments and supplies, as needed
Track and follow-up on serious adverse events as assigned
Implement study-specific communication plan as assigned
Attend investigators’ meetings, project team meetings and teleconferences, as needed
Assist Senior CRA in managing investigator site budgets
Education / Qualifications
Life Science degree; biomedical- medical-, paramedical or health-related area
3 lingual (French, Dutch and English)
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).
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Job Number 2018-21723
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.