We are currently looking for talented Clinical Research Associates to 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.
- 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