Are you a CRA with at least a first experience and are you open for a new challenge?
Or are you more experienced and ready to develop your career?
We can offer you a nice opportunity to contribute to the development of clinical trials at a well-known pharmaceutical company, with a strong portfolio in oncology, metabolic diseases, cardiology, respiratory and immunology.
As a CRA you will be responsible for preparation, initiation, monitoring and closing clinical trials and be the central point of communication between the pharmaceutical company and the investigative sites for all clinical trial related activities. The CRA works in close collaboration with other CRAs and the Local Study Team to ensure that quality and milestones are achieved.
- 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 eTMF updates.
- 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 your study sites.
- Perform source data verification and source data review.
- Ensure accurate and timely reporting of Serious Adverse Events.
- Prepare for activities associated with audits and regulatory inspections.
- 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.
Education, Qualifications and Experience:
- Master or bachelor degree in related discipline, preferably in life science, or equivalent qualification;
- Previous experience as a CRA, being able to monitor independently;
- Good understanding of Clinical Study Management including monitoring, study drug handling and data management;
- Knowledge of the ICH-GCP, local legislation and procedures;
- Good medical knowledge in relevant therapeutic areas is an asset: oncology, cardiology or pneumology;
- Excellent written and verbal communication skills in the country’s native languages and English
- Good analytical and problem-solving skills;
- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines.
- Enthusiastic and eager personality;
- Flexible, accurate and high level of integrity;
- Excellent computer skills;
- Drivers license.