Clinical Research Associate (CRA)
This job is no longer accepting applications.
- Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
- Acts as primary local company contact for assigned sites for specific trials.
- Attends/participates in investigator meetings as needed.
- Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
- Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
- Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
- Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
- Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and SharePoint).
Required Experience And Qualifications
- A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
- Must have experience in Clinical Research or equivalent qualification
- Usually 0-2 years' experience monitoring on site.
- Specific therapeutic area experience may be required depending on the position.
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
- Strong IT skills in appropriate software and company systems.
- Willingness to travel with occasional overnight away from home.
- Proficient in speaking and writing in Dutch & English, French is a strong plus and trilingual profiles are preferred (Eng + NL + intermediate FR minimum)
- In possession of a valid B driving license.
Why This Role Is Right For You
We offer an exciting and challenging work environment for clinical research professionals looking for an opportunity to contribute to the success of a companies dedicated to researching, developing, manufacturing and marketing pharmaceuticals that improve health and quality of life.
Why join the DOCS team at ICON?
Working at ICON is more than a job, it's a calling for people who care and are passionate about improving patients' lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
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