Senior CRA (Tel Aviv) 6048

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Senior CRA (in Tel Aviv) 6048

As Senior CRA you will execute clinical monitoring activities at clinical trial sites and monitoring clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs. Collaborating with the Regional Clinical Operations Manager, ensuring study timelines are adhered to and required quality standards are maintained.

Main Responsibilities:

• Performing monitoring activities related to selection, initiation, conduct (recruitment, quality data collection), and timely completion of oncology/hematology clinical trials within the assigned region

• Identify gaps and areas for improvement and propose CAPA

• Supporting start-ups and provides local expertise

• Performing feasibility, site identification, selection, and evaluation, preparing/supporting

initial list of sites and recruitment targets

• Providing protocol and related study training to assigned sites

• Conducting monitoring (pre-study, initiation, routine monitoring, and closeout) visits per

monitoring plan and applicable SOPs

• Completing monitoring visit reports in accordance with ICH-GCP, company standards, and SOP’s

• Managing sites and site performance by tracking regulatory submissions, recruitment, case

report form (CRF) completion, and data query resolution

• Ensuring inspection readiness of the study and sites

• Attending disease indication project-specific training and general CRA training as required

• Facilitating Study Oversight Visits (SOVs), site audits and/or inspections, as required

• Anticipating and identifying site issues; propose corrective and preventative actions; identify gaps

and utilize opportunities. Constantly strive for operating excellence, question status and promote

innovation.

Qualifications and Experience:

• Understands clinical trial processes with a thorough knowledge of ICH and associated

regulatory guidelines

• Ideally 5+ years of (CRA) monitoring experience in the pharmaceutical or CRO industry

• Efficient in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook Other

• Excellent communication and interpersonal skills

• Excellent organizational skills and ability to prioritize and multi-task

• Fluent in both Hebrew and English

• Divers licence

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us.