Clinical Trial Coordinator – FSP

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

📋 Description

• Coordinate, manage, and execute assigned clinical trial activities in alignment with the task matrix.

• Conduct reviews of department, internal, country, and investigator files, documenting findings accordingly.

• Ensure that assigned tasks are completed punctually, within budget, and adhere to high-quality standards.

• Process documents within the client (e)TMF, carry out (e)TMF reviews, manage communications, and provide necessary documents and reports.

• Review and monitor local regulatory documentation.

• Analyze and reconcile study metrics and findings reports.

• Maintain vendor trackers and study status information in databases.

• Coordinate and distribute materials for the Investigator Site File, Pharmacy binder, and non-clinical study supplies.

• Assist with study-specific translation materials and oversee translation quality control.

• Offer technical and administrative project support to internal departments and team members.

• Train new staff and support process enhancement initiatives.

• Maintain study documentation, team lists, training requirements, system access, and activity plans.

• Assist with Activate, eTMF, RBM, regulatory submissions, IRB/IEC document transmissions, meetings, and meeting minutes.

• Coordinate site start-up activities and prepare regulatory compliance review packages.

• Gather site-selection documents and compile site lists from both internal and external sources.

• Keep updated contact details for investigators and site staff, documenting site communications in CTMS.

• Review survey data and follow up with sites to ensure project deadlines are met.

• Conduct feasibility interviews and contribute to global feasibility processes and best practices.

• Provide financial support including raising and amending POs, creating vendors, managing cross-charging, addressing finance queries, and tracking/reporting/forecasting budgets, as well as supporting Veeva Payments and invoicing.

⛳️ Requirements

• High / Secondary school diploma or an equivalent qualification, along with relevant formal academic or vocational credentials.

• Bachelor's degree is preferred.

• Prior experience that provides the necessary knowledge, skills, and abilities to fulfill the job, typically at least 2 years.

• Equivalency may be established through a combination of relevant education, training, and/or directly related experience.

• Strong organizational abilities and meticulous attention to detail, capable of managing multiple tasks effectively.

• Ability to analyze project-specific data/systems to ensure accuracy and efficiency.

• Familiarity with pertinent country regulations, ICH Good Clinical Practices, and organization/client SOPs and WPDs.

• Excellent English language proficiency, including grammar, along with proficient local language skills as required.

• Proficiency in MS Office (Word, Excel, PowerPoint) and capacity to learn clinical trial database systems.

• Ability to successfully complete the organization's clinical training program.

• Strong oral and written communication skills, including effective communication with medical personnel.

• Basic knowledge of the medical/therapeutic area and medical terminology.

• Fundamental understanding of local health systems.

• Working knowledge of GCP and applicable SOPs.

• Capacity to operate in a matrix environment and manage risk appropriately.

• Familiarity with or ability to learn CERPS, Ariba, Fiori, and Veeva Payments.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday to Friday work schedule.