Clinical Trial Coordinator

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

📋 Description

• Coordinate, manage, and finalize assigned trial activities as per the task matrix.

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

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

• Proactively communicate project risks to project leads.

• Provide system support for Activate and eTMF, ensuring that system databases are up-to-date.

• Process documents sent to the client eTMF, conduct eTMF reviews, manage mailings and communications, and supply documents and reports to internal teams.

• Analyze and reconcile study metrics and findings reports.

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

• Support translation of materials and ensure translation quality control.

• Maintain familiarity with SOPs, client directives, and regulatory guidelines.

• Conduct on-site feasibility visits when applicable for Asia Pacific roles.

• Assist in scheduling client and internal meetings.

• Review and monitor local regulatory documents.

• Support activities involving risk-based monitoring.

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

• Transmit documents to clients and to the centralized IRB/IEC.

• Keep vendor trackers updated.

• Assist with regulatory submissions.

• Obtain site-selection documents directly from sites.

• Help with regulatory compliance review packages.

• Coordinate with internal departments to synchronize site start-up activities with the site activation critical path.

• Complete Site Interest Plans in CTMS and gather associated documents as needed.

• Document communications, follow-ups, and survey responses in real time.

• Review survey data for logical consistency, completeness, and relevance.

• Collaborate with team members and clinical staff regarding site issues and risks.

• Ensure effective site contact and follow-up plans, escalating non-compliance as necessary.

• Serve as a local expert on site capacity and experience, recommending additional sites as appropriate.

• Liaise with Global Investigator Services to address investigator queries and maintain account and contact information.

• Contribute to global feasibility processes and best practices.

• Train new personnel in relevant processes and systems.

• Utilize local knowledge to identify and develop new sites.

⛳️ Requirements

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

• Bachelor's degree is preferred.

• Prior experience of approximately 0 to 1 year is required.

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

• Capability to work both collaboratively in a team and independently.

• Strong organizational capabilities and meticulous attention to detail.

• Proficiency in managing multiple tasks efficiently and effectively.

• Ability to analyze project-specific data and systems.

• Strong customer orientation.

• Flexibility in reprioritizing workload as necessary.

• Working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organizational/Client SOPs and WPDs.

• Good command of the English language and grammar.

• Proficient in the local language of either Swedish or Danish.

• Skilled in MS Office applications (Word, Excel, and PowerPoint).

• Ability to learn and master clinical trial database systems.

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

• Strong oral and written communication skills.

• Essential judgment and decision-making abilities.

• Diligence in accurately following project work instructions.

• Good negotiation capabilities.

• Ability to manage risk and appropriately escalate risk issues.

🏝️ Benefits

• Fully remote work arrangement if based outside of Copenhagen or Stockholm.

• Hybrid work model if based in Copenhagen or Stockholm.

• Standard work schedule from Monday to Friday.