Senior CRA (oncology)

For our Client Top Pharmaceutical Company ICON seek for candidates for the role of Snr CRA in FSP model for one of our Clients, Top Pharmaceutical Company. This is an hybrid role. Oncology experience is a must. New Hire will be allocated to Early Development Oncology studies.

Roles & Responsibilities of the position

•Identify, evaluate and recommend potential study sites for participation based on feasibility and protocol outline to LTM.

•Perform pre-trial assessment visits to determine site qualifications and evaluate possible participation.

•Coordinates site initiation visits to ensure timely study start up.

•Perform Monitoring visits as required.

•Assures that site personnel complete and document protocol-specific training.

•Conducts ongoing study visits as required by SOP and project team.

•Performs source documentation as required by SOP to ensure protocol/patient compliance; reports any site issues to LTM or Clinical Team.

•Performs drug accountability and any re-labelling that may be required.

•Responds to site questions and escalates to LTM as necessary for resolution.

•Remains current in all SOP and protocol related training.

•Attends investigator meetings.

•Participate in QA or FDA audits when necessary.

What is required:

• A life science / healthcare related degree or equivalent work experience.

• Minimum 3 years of solid independent monitoring experience. (Oncology experience is a must)

• Solid understanding of clinical trial design, trial execution and operations.

• Knowledge of international standards (GCP/ICH), international (FDA, EMEA) and local regulations.

• Expertise in communication, managing multiple priorities and computer literacy.

• Proven people management skills with demonstrated expertise in working in a team.

• Fluency in English as well as Hebrew.

• Availability to travel at least 60% fly and drive and should possess a valid driving license.