Biond Biologics Ltd
- 29/11/2023
- עכו
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
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