Clinical Trial Associate
The Clinical Trial Associate is responsible for supporting the Study Team and Clinical Trial Manager and contributing to the operational execution of clinical trials to ensure on time completion, within budget and of high quality in compliance with all applicable regulations, guidelines and Standard Operating Procedures.
- Involvement in various tasks to support the Study Team/Management with any trial related activities in all phases of the conduct of the clinical trial;
- Assist in the preparation of study specific tools (including communication tools such as study specific websites, newsletters, flyers etc.);
- Support CTM in the set-up and maintenance of study specific trackers to ensure continuous oversight of the study progress;
- Manage all study-related supplies;
- Prepare study reports and keep required tools and tracking databases up to date as required;
- Ensure that clinical trials are conducted in accordance with the protocol, Good Clinical Practice regulations, and internal Standard Operating Procedures;
- Perform ongoing quality checks/review of documents for the Trial Master File and follow up;
- Support CTM in preparation and follow-up after site, vendor or sponsor audits.
Qualifications and Experience:
- Bachelor's degree in Nursing, Medicine or other Life Sciences or RN degree from an accredited school;
- Minimum of 2 year experience of clinical trial management (experience as CRA is an advantage);
- Knowledge of ICH/GCP guidelines (accredited GCP course desirable);
- Experience in identifying potential deficiencies in the trial progress and assisting in/suggesting corrective and preventive actions (CAPA);
- Fluency in English (verbal and written) and excellent communication skills;
- Ability to efficiently organize and prioritize work within a multifaceted framework and set deadlines;
- Excellent organizational and record-keeping skills with high standards and attention to detail;
- Flexible, proactive, open-minded and hands-on attitude;
- Relevant working/residency permit or Swiss/EU-Citizenship required.