Senior Clinical Research Associate

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Facilitate the identification, feasibility evaluation, and selection of investigators and sites for trial execution.

• Conduct all monitoring activities in accordance with the Monitoring Plan, ensuring monitoring visit reports are completed accurately and within set timelines.

• Prepare, plan, organize, and execute site evaluation visits, providing reports on these visits to aid in site selection.

• Prepare, submit, and/or collaborate with regulatory specialists regarding the development of regulatory packages, import/export requirements, and updates for Ethics Committee submissions.

• Negotiate site budgets, oversee site contract execution, track invoicing, and guarantee timely payments to sites.

• Prepare, plan, organize, and carry out site initiation visits.

• Create and maintain necessary monitoring tools and project-specific documentation.

• Inspire and train investigators to ensure that trial site personnel understand the protocol, investigational product, and trial requirements, enabling them to meet their obligations accurately and on time.

• Gather, review, and approve essential documents from trial sites to ensure quality and compliance, coding documents for Trial Master File (TMF) organization.

• Reconcile the contents of the in-house TMF with the site’s Investigator Site Files.

• Coordinate the distribution, tracking, handling, and disposal of investigational products and other trial supplies according to site/trial specifications.

• Maintain trial information using the clinical trial management system and other tracking and reporting tools relevant to the trial.

• Support initiatives aimed at enhancing recruitment efforts.

⛳️ Requirements

• A degree in a relevant science or healthcare discipline.

• Previous experience in clinical trials within an academic, CRO, or pharmaceutical setting, with 2-5 years of on-site monitoring and site management experience is essential.

• Proven practical knowledge of ICH-GCP guidelines and both global and local ethical and regulatory research standards.

• Competence in areas such as ethical and participant safety considerations, site start-up management, site conduct management, risk management, quality management, supply management, scientific concepts, clinical research design, and issue escalation management.

• Proficiency in business skills including negotiation and conflict resolution, critical thinking, problem-solving, decision-making, and strategic thought.

• Strong interpersonal communication and presentation skills, with the ability to work effectively in a multi-disciplinary team and engage with a diverse range of stakeholders.

• Flexibility and adaptability in response to changing organizational priorities and uncertain environments.

• Willingness and ability to travel as needed.

🏝️ Benefits

• Competitive Compensation: A customized salary and benefits package that reflects your skills and experience.

• Flexibility: Enjoy the option of hybrid or remote work arrangements, based on your location and role.

• Career Growth: Access to a plethora of learning opportunities and a global network of scientific leaders to aid in your professional development.

• Employee Wellbeing: Engage in programs and initiatives designed to foster work-life balance, health, and team connectivity, including global engagement surveys, recognition programs, and team-building events.

• Global Opportunities: Join a company with international reach, providing exposure to a variety of projects and clients.