Do you like to coordinate and monitor (inter)national, multicentre clinical trials in order to assure the quality of the clinical data? Then this could be the opportunity to develop your career at our Scientific CRO! We are actively looking for a talented and proactive Clinical Research Associate with strong communication and negotiation skills and with willingness to travel on an irregular base.
You will be part of the CRA team, currently existing of 15 CRA’s, and you will report to the Manager Clinical Monitoring.
Tasks and responsibilities
- Monitors clinical research in accordance with the protocol, SOPs, applicable laws and ICH-GCP guidelines, including visit report compilation and follow-up within the set timelines;
- Performs feasibility, site selection, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices, applicable laws and regulations SOPs and Work Instruction
- Performs Feasibility, Medical ethics Committee Health authority activity and can be involved in contract negotiation activities with investigator or hospital;
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalates quality issues to Clinical Team Lead and/or Linemanager;
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution;
- Train investigators and site staff (including laboratory, pharmacy and other staff involved) in the correct implementation of the protocol, the CRF and study-specific procedures and establish regular lines of communication with sites to manage ongoing project expectations and issues. And assists to organize CRA/ Investigator meetings, if applicable.
- Develops and maintains an effective working relationship with site staff.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action items by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation
- Ensures the correct reporting and follow-up of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions;
- Supports the investigator during inspections by healthcare authorities or audits
- Is involved in SOP development, maintenance and training
- Possibly: international initiation visits & monitoring visits
The ideal candidate has:
- Higher level of education preferably in an (bio)medical field;
- At least one year of relevant experience, as a CRA, in clinical research;
- Up- to- date knowledge ICH-GCP guidelines, clinical trial regulations and legislation;
- Effective oral and written communication skills in English and Dutch;
- Proactive, strong communication and negotiations skills;
- Ability to work independently as well as in a team matrix organization.
- Ability to travel on an irregular base;
- Practical knowledge of Microsoft Office;
- Driver’s License
- An open culture in an innovative and dynamic environment with inspiring colleagues and good working conditions.
- An environment where you have room to be creative, take initiative and have direct influence on the way we work.
- We are located in a beautiful monumental building, near Slot Zeist, close to public transport.
- Our employees have the flexibility to work from home or from the office or a combination of the two.
How to apply
Interested in this position? Apply below or send your CV and motivation to firstname.lastname@example.org
If you have further questions you can contact call Ellen Hunink (HR Business Partner, 06-2116 2980) or Floor Hobbelink (Manager Clinical Monitoring 06-46435726)