Clinical Research Associate
CK QLS are recruiting for a Clinical Research Associate to join our client based in Basel, on a 12 month contract.
RESPONSIBILITIES AND TASKS :
- Review and provide input on requested trial-related documents and on any CRO prepared documents, e.g., protocol and protocol amendment, Informed Consent Form, Delegation of Authority, Case Report Form, Study-Specific Monitoring Plan (SSMP), trial forms, source document templates, Clinical Study Report.
- Contribute to the collection and the quality control of essential documents.
- Participate in and contribute to the Clinical Pharmacology trial team meetings by providing updates on monitoring activities.
- Contribute to the CRO / Site selection process by sharing any experience with a CRO / Site (when required).
- Perform accompanied visits, qualification visits (when required) and initiation visits as internally agreed for the assigned studies.
- Schedule and conduct routine remote and / or on-site 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.
- Ensure that the conduct of the assigned trials complies with ICH-GCP Guidelines, local regulations, working instructions (WIS) and Standard Operating Procedures (SOPs).
- Identify CRO / Site issues, ensure resolution, and / or escalate issues if necessary.
- Report to the Clinical Pharmacology trial team and the CRO / Site staff any findings noted during onsite and remote monitoring visits by completing contact reports, monitoring visit reports and follow-up letters as per Idorsia processes.
Manage the assigned CRO / Site(s) through regular contacts to ensure about :
Site compliance with regulatory requirements and ethical standards throughout the tria.Adequate enrolment and understanding of trial requirements.Operate as a central communication link between the Clinical Pharmacology trial team and the CRO / Site staff from the time of the IRB / IEC approval to the close-out visit, for the assigned trials.Manage all trial 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 CRO / Site to the bioanalytical laboratory or central laboratory (when appropriate).REQUIRED QUALIFICATIONS AND EXPERIENCE :
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 (CRO) or Pharmaceutical Company with experience in monitoring on-site clinical trial.Strong knowledge of ICH-GCP guidelines and other applicable regulatory requirements.Understanding of drug development process.Excellent interpersonal skills, able to motivate the site staff and implement the study successfully.Excellent oral and written English communication skills; any other language is advantageous.APPLY :
Please contact Rob Angrave for more information or to apply for this role. Please quote 106439 in all communication. It is essential that applicants hold entitlement to work in Switzerland.