Remotery

Clinical Trial Coordinator

Posted 22 hours ago

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

📋 Description

• Depending on the designated role (Central or Local), coordinates, manages, and finalizes tasks related to assigned trial activities outlined in the task matrix.

• Conducts reviews of department, internal, country, and investigator files as assigned, documenting findings in the appropriate system.

• Ensures that assigned tasks are executed punctually, within budget, and to a high-quality standard. Proactively communicates any potential risks to project leads and line management as necessary.

• Aids in maintaining study-specific documentation and provides global support with particular systems, tools, and trackers, including but not limited to: study team lists, tracking project-specific training requirements, managing system access for the organization/vendor/clients, and monitoring project-level activity plans in the appropriate system. Ensures (e)TMF is current by adhering to file review schedules and documenting findings in the relevant system.

• Offers system support (i.e., GoBalto & eTMF).

• Assists with Risk-Based Monitoring (RBM) activities.

• Executes administrative duties for assigned trials, including but not limited to: timely processing of documents sent to Client (e)TMF as assigned, conducting (e)TMF reviews, performing mass mailings and communications as needed, and providing documents and reports to internal team members.

• Aids in the scheduling and organization of client and/or internal meetings, including the completion of related meeting minutes.

• Reviews and monitors local regulatory documents.

• Sends documents to clients and centralized IRB/IEC.

• Analyzes and reconciles study metrics and findings reports, assisting with the clarification and resolution of issues related to site documentation.

• Maintains vendor trackers.

• Assists in the coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials, as well as non-clinical study supplies to sites.

• Supports the creation of study-specific translation materials and performs translation quality control upon request.

• May attend kickoff meetings and take notes when necessary.


⛳️ Requirements

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

• Bachelor's degree is preferred.

• Previous experience providing the knowledge, skills, and abilities necessary to perform the job (equivalent to at least 4 years).

• Ability to work collaboratively in a team or independently as required.

• Strong organizational skills and attention to detail, demonstrating a proven capacity to manage multiple tasks efficiently and effectively.

• Proven ability to accurately analyze project-specific data/systems to ensure both precision and efficiency.

• Strong focus on customer satisfaction.

• Demonstrated flexibility and adaptability to re-prioritize workload and provide effective support to accommodate changing project timelines.

• Proven ability to acquire and maintain a solid understanding of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all aspects of project implementation, execution, and closeout.

• Excellent command of the English language and grammar, with proficient local language skills as necessary.

• Good presentation skills.

• Excellent computer literacy, proficient in MS Office (Word, Excel, and PowerPoint) and capable of mastering all clinical trial database systems.

• Ability to successfully complete the PPD clinical training program.

• Self-motivated with a positive attitude and effective interpersonal skills.


🏝️ Benefits

• Health insurance.

• Professional development.

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