Clinical Trial Assistant (70-100%) - immediately available
Our client, a dynamic clinical-stage biopharmaceutical company headquartered in Switzerland focusing on developing drugs in oncology and ophthalmology, is looking for a Clinical Trial Associate (70-100%) to start as soon as possible on a contract based in the Zürich area.
The ideal candidate should have at least 1-2 years of experience as a Clinical Trial Associate or equivalent position.
- Track distribution of electronic and paper copies of IBs and Clinical Study Reports (CSRs) to internal and external parties as well as regulatory authorities and IRBs/IECs;
- Ensure a Q&A log is set-up and kept up-to-date (if Q&A log is requested for a trial) and shared with the relevant team members;
- Support set up of (e)TMF and (e)TMF specifications;
- Ensure the (e)TMF is up-to-date and all documents are filed as necessary and in strict compliance with ICH/GCP, regulatory requirements and internal SOPs;
- Support interactions with an insurance company/broker (i.e., request offers, review cost proposal and conditions, review insurance documents and certificates, ensure protocol amendments are provided to insurance company/broker, etc.);
- Provide input to synopsis and clinical protocol (e.g., calculate blood volume), if requested;
- Support CSR writing by providing relevant documents and information (e.g., protocol and all amendments, protocol deviations, SAP, CRFs, IB, etc.);
- Support review of status reports sent by CROs, plans and guidelines and follow-up on any issues, if requested or assigned by CTM to do so;
- Support CTM with developing the Monitoring Plan by reviewing the trial specific risk management plan and ensuring the identified risks are taken into account when developing the Monitoring Plan;
- Support CTM in reviewing protocol deviations, updating trackers and presentations and preparing internal protocol deviation review meetings;
- Support CTM in IRB/IEC submission process by reviewing submission packages and ensuring consistency between the application packages for the IRB/IEC and CA/RA for the documents in common (for initial submission as well as amendments);
- Support CTM in submitting the final CSR to IRB/IEC by reviewing the CSR submission package and ensuring consistency with CA/RA CSR submission package and responsible to keep track of approval status;
- Support team with CA/RA inspection or audit preparations and attend in person, if necessary.
- Support the clinical team by updating regularly all trial information tracking systems in order to manage accuracy of information;
- Assist with drug supply and laboratory kits management for the clinical trials;
- Perform assigned administrative tasks to support team members with clinical trial execution, e.g. planning and organization of investigator meetings, create agendas and meeting minutes.
- Track and keep record of patient enrollment;
- Track all information sent to the Legal Representative;
- Report potentially serious incident related to GCP or the trial protocol and keep an eye on signs of fraud.
Qualifications and Experience:
- BSc Degree or equivalent education/degree in life science/healthcare;
- 1-2 years of experience as a CTA or equivalent position;
- Basic knowledge of international standards (GCP/ICH), health authorities (FDA, EMA), local/National Health Authority regulations;
- Knowledge of applicable protocol requirements as provided in company training;
- Ability to establish and maintain effective working relationships with co-workers, managers and vendors;
- German and English (a must), any other language is a plus;
- Profound knowledge of MS Office package (i.e., Word, Excel, PowerPoint);
- Effective time management and organizational skills;
- Strong communication and planning skills;
- Attention to detail and accuracy in work;
- Strong database skills;
- Can do attitude; pragmatic problem solving capabilities.