Clinical Research Associate

An innovative clinical-stage biopharmaceutical company in the field of Immunotherapy located in the North of Israel is searching for a full-time Clinical Research Associate (CRA) to join our growing team.

The CRA will be responsible for clinical activities, as follows:

Supervising study sites to ensure adherence to study protocol, applicable regulations, SOPs, ICH-GCP and study plans

• Acting as the primary local contact for assigned sites and responsible for monitoring the sites
• Contributing to site level recruitment strategy, planning and implementation with other functional areas to achieve clinical research goals
• Ensuring study supplies are adequate for trial conduct
• Ensuring that all AEs/SAEs are reported within the required reporting timelines and are appropriately documented
• Performing Source Data Verification activities
• Maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. EDC, CTMS, eTMF, Sharepoints)
• Ensuring the sites’ staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases

Requirements:

• A Life science/Healthcare related degree
• A minimum of 3 years experience as a CRA. Previous experience in conducting oncology studies. Experience with early-stage studies is an advantage
• Understanding of clinical trial design, trial execution and operations
• Knowledge of international standards (GCP/ICH), international (FDA/EMEA) and local (MoH/ECs) regulations
• Ability to prioritize tasks and resources, meet deadlines, be flexible and adjust to changing priorities
• Well organized and attention to details
• Excellent people management and communication skills, a true team player -a must
• Fluency in English as well as Hebrew
• Ability to travel, a valid driving license