Clinical Research Associate

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.