Clinical Research Associate

Key Responsibilities

• 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 enrolment, 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 / ICH 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.
• Act as a mentor for clinical staff including conducting co-monitoring and training visits with CRAs.
• Supports the Clinical Research Associates (CRAs) with site monitoring activities and provides suggestions and solutions to site issues where applicable
• Coordinate end-to-end cross-functional project operations and multi-disciplinary activities to ensure that project deliverables are met
• Monitor progress of project activities and deliver frequent updates to the Project Leader and Team
• Involved in coordination with legal team to prepare and review and/or to execute agreements with investigators and vendors (Master service and/or amendment, CDA, NDA)
• 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.

Qualifications & experience required

• At least 2-3 years of independent on-site monitoring experience.
• Experience in all types of monitoring visits in Phase II and/or III (Oncology Preferred)
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Strong therapeutic and protocol knowledge as provided in company training.
• Computer skills include proficiency in using Microsoft Word, Excel and PowerPoint and using a laptop computer.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Ability to travel domestically as needed to study sites and for training and meetings.