Sr. Clinical Research Associate (Israel)

• Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation.
• Track and supervise collection of ongoing study data for purpose of regular project status reporting as required.
• Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies.
• Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines.
• Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
• Collect and review regulatory documents as required.
• Prepare site visit and telephone reports.
• Responsible for multiple projects and must work both independently and in a team environment.
• May participate in the study development and start-up process including reviewing protocols, drafting of the Monitoring Plan, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.
• Resolve site issues and determine status for IP shipment.
• Work with Project Manager (PM), Clinical Team Leader (CTL) and/or Lead Clinical Research Associate (LCRA), regulatory team members or Sponsor to secure authorization of regulatory documents and contracts.
• May translate, coordinate translations or review completed translations of critical documents.
• Participate in feasibility and/or site identification activities.
• Assist the Project Team with the day-to-day management of clinical studies as required.
• Monitoring Visit Report (MVR) review, management, resolution and escalation as required.
• Train, mentor and/or supervise junior staff.
• May be assigned as LCRA to a regional or global study.
• May be assigned as a reviewer of essential documents (GLP) as a 2nd line or Independent Reviewer (IR).
• Conducts project co-monitoring, assessment visits and team training.
• Site contact for protocol clarifications and subject enrolment if CRA unavailable.
• Participate in the development of study newsletters communication as required.
• Assist with the development of project-specific training materials for team.
• Liaise with Business Development and make presentations to potential clients as required.
• May be required to manage the preparation of local clinical trial applications (for regulatory submissions for new drugs, biologics, or devices).

• At least 4 years experience.
• Skills to mentor and train other CRAs in a positive and effective manner.
• In-depth knowledge of clinical trials and the critical elements for success in clinical trials.
• Ability to travel for up to 8 days on site per month, depending on the project needs.
• Strong therapeutic background.
• Has shown ability to successfully manage people/project issues.
• Mature management skills demonstrated by calm and thorough review of situations. Proactively identifies and addresses problems. Seeks to understand all contributing factors. Proposes, implements, and evaluates appropriate resolutions.
• Demonstrates the ability to define and meet project requirements.
• Can demonstrate flexibility for improvement and creating solutions.
• Proven organizational abilities, and excellent written and oral communication and presentation skills.
• Excellent team player with team building skills.
• Strong customer focus.
• A thorough knowledge of regulatory submission and reporting requirements and guidelines.
• Excellent understanding of the drug development process.

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/hybrid* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via GoodHabitz and internal platforms
• Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
• Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

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