Senior Clinical Research Associate

Role Overview

• Coordinate the identification, feasibility assessment, and selection of investigators and sites to undertake the trial.
• Complete all monitoring activities per the Monitoring Plan along with completing monitoring visit reports, accurately and within the predetermined timeframe.
• Prepare, plan, organise, and conduct site evaluation visits and report on these visits to assist with site selection.
• Prepare, submit, and/or liaise with regulatory specialist colleagues, regarding the preparation of regulatory packages, importation/exportation requirements, and updates of Ethics Committee packages.
• Negotiate site budgets, coordinate for site contract execution, track invoicing, and ensure timely site payments.
• Prepare, plan, organise, and conduct site initiation visits.
• Develop and maintain appropriate monitoring tools and project-specific documents.
• Motivate and train investigators to ensure that the trial site personnel have a good understanding of the protocol, investigational product, and requirements of the trial so they can fulfill their obligations to conduct the trial accurately and to deadlines.
• Manage trial sites utilising both on-site and off-site activities including:
• Verification of quality, accuracy, completion, and timeliness of data.
• Ensure complete and efficient resolution of data queries, audits, issues, and liaise with Data Management and/or Quality colleagues, as needed.
• Adhere to the trial protocol, all applicable project-related plans, as required by the project training matrix, and other relevant project-specific requirements.
• Adhere to ICH/GCP and other regulatory guidelines and requirements as relevant to this trial including reporting of subject safety
• adverse/serious adverse events, protocol violations/deviations, and liaise with safety colleagues as needed.
• Ensure targets, metrics, and quality are maintained per trial expectations.
• Identify risks associated with e.g., clinical trial design, privacy and confidentiality, clinical trial misconduct, and take action to mitigate risk proactively and to escalate as appropriate.
• Collect, review, and approve essential documents from trial sites, to ensure quality and compliance, and code documents for Trial Master File (TMF) filing.
• Reconcile contents of in-house TMF and site’s Investigator Site Files.
• Coordinate distribution, tracking, handling, and destruction of investigational product and other trial supplies per site/trial requirements.
• Maintain trial information using the clinical trial management system and any other tracking and reporting tools for the trial.
• Support strategies to boost recruitment efforts.
• Coordinate and perform translation verification of regional language, as required or as applicable per region.
• Perform site close-out visits and other site activities including archiving, as applicable.
• Mentor, coach, and train junior staff members as directed by line management.
• Perform any additional responsibilities assigned by the Line Manager and/or Project Lead.

Requirements

• Educated to degree level in pharmacy, medical, nursing, biological science, or other health-related disciplines preferred or equivalent relevant experience.
• More than 5 years experience in clinical trial monitoring and/or site management within a contract research organization, or pharmaceutical environment.
• Experience with Oncology trials is highly regarded.
• Displays high competence in the following technical areas: ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts and clinical research design, and issue escalation management.
• Demonstrate high competence in the following skill areas: negotiation and conflict resolution, critical thinking, problem-solving, decision making, and strategic thinking.
• Demonstrates solid interpersonal communication skills, presentation skills, is flexible, and can work well within a multi-disciplinary team both autonomously and with a wide range of varying stakeholders.

Tech Stack

• Google Cloud Platform

Benefits

• Competitive Compensation : A tailored salary and benefits package to reflect your skills and experience.
• Flexibility : Enjoy hybrid or remote working arrangements, depending on your location and role.
• Career Growth : Access to a wealth of learning opportunities and a global network of scientific leaders to help you grow and develop in your role.
• Employee Wellbeing : Participate in programs and initiatives designed to promote work-life balance, health, and team connection, including global engagement surveys, recognition programs, and team-building events.
• Global Opportunities : Be part of a company with international reach, offering you exposure to diverse projects and clients.