Mantell Associates is currently partnered with a Global leading CRO based in the Israel, Managing their search for a Clinical Research Associate.
Are you looking to join a leading international CRO?
Are you looking for a business Focussed on internal Development?
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
• Collaborate and liaise with study team members for project execution support as appropriate.
• If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis.
• If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement.
Benefits Package will include at a minimum:
1. Pension – according to the law.
2. Education fund.
3. Vacation days – scale of 16 up to 24.
4. Company car or car allowance.
5. Health insurance.
6. Daily allowance for site visit
Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm.
For more information on this role, please contact George Hebden Lee on +44 (0)20 3854 7700 or George.email@example.com