What about joining a growing international CRO which operates in more than 18 countries? Do you have a Life Sciences background, interest in (bio) pharmaceuticals and enjoying flexibility?
For our client, a CRO in pharmaceuticals, we are looking for a Clinical Research Associate homebased.
Our client is a clinical research organisation (CRO) in Europe. They operate in over 18 countries in the region with an experienced staff comprised largely of physicians and PhDs. They serve global pharmaceutical and biotechnology companies in the development of new medicines and modern medical technologies. The company has operations throughout Europe and since starting 18 years ago, they have expanded significantly.
Their international clients value the enthusiastic, flexible and quality-focused professional approach to meeting their needs.
For more detailed information please feel free to contact Mrs. Sari Steenhauer, tel. 0031 (0)6 33 13 77 46.
As a Clinical Research Associate you will be expected to actively participate in and manage the recruitment of potential investigators and perform CA and EC submissions. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study, initiation visits, regular visits and close out visits and liaison with vendors and other duties. You will function as the primary contact for sites regarding regulatory compliance and protocol questions and communicate with clinical sites on an ongoing basis to address and resolve issues. Reporting to Clinical Operations Lead, you will be a key member of the Clinical Operations team in the NL.
We are searching for ambitious and energetic person, able to undertake challenges in the project, push forward development of the project and function well in the project team. The desired person shall be open to cross cultures communication and cooperation and shall be significantly independent in their performance.
- Responsible for recruitment of potential investigators, involvement in CA and EC submissions and notifications to regulatory authorities, organization of meetings and other tasks as instructed by supervisor;
- Responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study initiation visits, regular visits and close out visits, assists on audit/inspection visits and assists in site and vendor contracting process, liaison with vendors and other duties;
- Functions as the primary contact for sites regarding regulatory compliance and protocol questions and communicates with clinical sites on an ongoing basis to address and resolve issues;
- Assists in Business Development activities;
- May have supervisory functions in clinical projects;
- May be required to train, coach and supervise junior staff.
- Excellent knowledge of the clinical trial process and ICH/GCP and local requirements/guidelines ;
- Excellent organizational and time management skills;
- Skills to handle multiple priorities and to work with deadlines and under pressure;
- Excellent written and oral communication skills;
- Skills to coach and mentor other clinical staff;
- Fluent in written and verbal English and Dutch;
- Computer skills.
What do we offer
- Working with experienced and very professional and supportive team;
- Possibility to grow within the company;
- Competitive remuneration;
- Flexible working time;
- Eligibility to the Company Bonus scheme;
T: 06 33 13 77 46.
When interested please react through the application process with your English resume.
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