Clinical Research Associate
Are you a CRA with at least a few years’ experience and you are up to a new challenge? Or you are more experienced and ready to develop your career further? We can offer you a nice opportunity to contribute to the development of clinical trials at a well-known pharmaceutical company. Please make yourself known !
The Clinical Research Associate (CRA) has responsibility for the delivery of the studies at allocated investigator sites and is an active participant in the local study team(s). She/he works in close collaboration with other CRAs and the Local Study Team to ensure that quality and quantity commitments are achieved in a timely and efficient manner. The CRA is responsible for the preparation, initiation, monitoring and closure of an agreed number of centres in clinical studies.
- Obtain and maintain essential documentation in compliance with ICH-GCP, the company’s Procedural Documents and local regulations both in the office and at site. Ensure completeness of the Trial Master File.
- Actively participate in local Study Team meetings.
- Contribute to the selection of potential investigators, train, support and advise Investigators and site staff in study related matters.
- Share information on patient recruitment and study site progress within local Study Team.
- Utilize Risk Based Monitoring approach including remote monitoring.
- Drive performance at the sites. Proactively identify study-related issues and ensure query resolution.
- Manage study supplies (ISF, CRF, etc.), drug supplies and drug accountability at study sites.
- Perform source data verification and source data review per SDV plan.
- Ensure accurate and timely reporting of Serious Adverse Events.
- Prepare for activities associated with audits and regulatory inspections in liaison with LSTL.
- Provide the required monitoring visit reports within required timelines (remote or on-site visits).
- Cooperate with Medical Science Liaisons in their support of the designated clinical studies.
Leadership and Functional Capabilities:
- Ability to deliver quality per the requested standards.
- Ability to work in an environment of remote collaborators and manager.
- Manages change with a positive approach for self, the team and the business. Sees change as an opportunity to improve performance and add value to the business.
- Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.
- Good analytical and problem-solving skills.
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Good cultural awareness.
- Team oriented and flexible; ability to respond quickly to shifting demands and opportunities.
Education, Qualifications and Experience:
- Master’s or bachelor’s degree in related discipline, preferably in life science, or equivalent qualification.
- Excellent knowledge of international guidelines ICH/GCP, basic knowledge of GMP/GDP.
- Good knowledge of relevant local regulations with main focus on Belgium.
- Good medical knowledge in relevant Therapeutic Areas is an asset: onco, cardio, pneumo
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management.
- Valid driving license
- Languages: English, fluent in Dutch or French
- Reside in Belgium