The candidate's mission is to assist the Clinical Manager in setting up, conducting and closing clinical studies in cooperation with all stakeholders. You will ensure the operational coordination of national and international clinical trials in compliance with regulations, deadlines and budget.
Arranging monitoring visits at appropriate time intervals and document according to SOPs,
Arranging close-out visits with sites and organizing on-site or off-site archiving; document activities as per SOPs, standard operating procedure.
Follow-up and resolve any issues arising from monitoring visits,
Writing visit reports and filing and collating trial documentation and reports,
Ensuring all unused trial supplies are accounted,
Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV),
Track completed CRFs sent to data management/locked EDC forms; track issued and resolved data queries.
Medical related scientific degree (Bachelor, Master, Nursing qualifications or similar degrees and/or experience),
1 year experience as a CRA, Clinical Research Associate, ideally in the medical device industry,
Your background has allowed you to develop your technical knowledge in onco-surgery, histopathology. You demonstrate an excellent knowledge of the regulatory and ethical environment of Clinical Studies.
Knowledge of the medical devices sector and strong scientific understanding,
Experience Strong working knowledge and understanding of ICH-GCP, ISO14155, MDD / MDR, Swiss laws and regulations governing clinical trials,
Excellent clinical trial monitoring skills with a high level of attention to detail and strong, organizational ability, excellent interpersonal skills and a good level of communication. A sense of responsibility and a spirit of initiative will be necessary qualities.
Computer skills (MS Office) and experience in eCRF system for Clinical Research, CTMS Systems, as well as eTMF Software,
English and French fluent written and spoken, German and Italian is a plus,
Willingness to travel as required.
We offer you:
An autonomous position in an international context,
A position rich in contacts and interaction,
A different daily routine every day,
You are joining a start-up company in full development.