Clinical Research Associate - Basel
Alex Tosney is recruiting for a Clinical Research Associate to join a rapidly growing company in the drug discovery area. The position will be offered on a 12 month contract at our clients site in Basel, with the possibility of extension.
The main purpose of the role will be to:
- Contribute to the collection and the quality control of essential documents required for the Investigational Medicinal Product (IMP) shipment approval
- Participate 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)
- Perform qualification visits (when required) and initiation visits as agreed with the Clinical Pharmacologist for the assigned studies
Further responsibilities will include:
- 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 (SOPs)
- Identify CR0/Site issues, ensure resolution, and/or escalate issues if necessary
- 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 as per Idorsia processes
- 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 (but not limited to) IMP and laboratory supplies, from receipt to return or destruction, as appropriate
- Supervise biological samples shipment(s) from the CR0/Site to the bioanalytical laboratory or central laboratory (when appropriate)
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- University degree in science or health-related discipline and/or degree in Nursing
- Clinical research experience in a Contract Research Organization (CRC) 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
- Clinical research experience in a CR0 or Pharmaceutical Company with experience in monitoring on-site clinical trials including experience in monitoring early phase clinical trials (i.e., phase 0, 1, 2a), phase 1 experience advantageous
- Excellent oral and written communication skills in English; German language is advantageous
This is an excellent opportunity to join a expanding pharmaceutical company.
For more information or to apply for this position, please contact Alex Tosney on 0041 (0) 41 7825 08443 or email atosney@ckqls.ch. Please quote reference 45931in all correspondence.
