Hobson Prior are looking for a Clinical Research Associate to join a growing biopharmaceutical company in Switzerland, who focus on discovering, developing and bringing more pioneering medicines to patients.
- Contribute to the collection and the quality control of essential documents required for the Investigational Medicinal Product shipment approval.
- Partake in and contribute to the Clinical Pharmacology study team meetings by providing updates on monitoring activities.
- Contribute to the CR0/Site selection process by sharing any experience with a CR0/Site (when required).
- Complete qualification visits and initiation visits as agreed with the Clinical Pharmacologist for the assigned studies.
- Schedule and conduct routine monitoring visits and close-out visits at the frequency determined for the assigned studies, assuring that the CROs/Sites are delivering high quality research, overall integrity of study implementation, and adherence to the protocol at the clinical sites.
- Ensure that the conduct of the assigned studies complies with ICH Guidelines, local regulations, and Standard Operating Procedures.
- Report to the Clinical Pharmacology study team and the CR0/Site staff any findings noted during monitoring visits by completing monitoring visit reports and follow-up letters.
- Manage the assigned CR0/Sites through regular contacts to ensure about.
- Operate as a central communication link between the Clinical Pharmacology study team and the CR0/Site staff from the time of the IRB/IEC approval to the close-out visit, for the assigned studies.
- Manage all study supplies, including IMP and laboratory supplies, from receipt to return or destruction, as appropriate.
- Capability to work self-sufficiently as well as being a team player and with a great attention to detaill.
- Able to deal with difficult situations with good problem-solving capabilities.
- Strong interpersonal skills able to motivate the site staff and implement the study successfully.
- Excellent oral and written communication skills in English (German language is admirable).
- Willing and able to travel as required in different countries.
- Proficient IT skills
- University degree in science or health-related discipline and/or degree in Nursing.
- Minimum 1-2 years clinical research experience in a Contract Research Organization or Pharmaceutical Company with experience in monitoring on-site clinical trials.
- Strong knowledge of ICH-GCP guidelines and other applicable regulatory requirements.
- Understanding of drug development process.
- Minimum 4-5 years clinical research experience in a CR0 or Pharmaceutical Company with experience in monitoring on-site clinical trials including 2+ years’ experience in monitoring early phase clinical trials (i.e., phase 0, 1, 2a), phase 1 experience advantageous.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.