Clinical Trial Coordinator - Monitoring (Remote)
About The Position
Under the oversight of the line manager, the Clinical Trial Coordinator-Monitoring is responsible for comprehensive trial and site administration, including preparing, collating, distributing, and archiving clinical documents. The role supports clinical and non-clinical supply management and maintains tracking and reporting tools. It helps meet planned Site Ready dates by assisting with IRB/ERC and Health Authority submission packages. The coordinator collaborates locally with Clinical Operations Managers, Clinical Research Managers, Clinical Research Associates, finance and budgeting representatives, and other country roles. The position covers trial and site administration; document management; regulatory and site start-up activities; budgeting, agreements, and payments; and meeting planning. Tasks include maintaining study records and databases, coordinating supplies and translations, supporting submissions and contracts, tracking payments and compliance, and coordinating investigator meetings and site visits.
Requirements
- Fluent in local languages and business proficient in English, verbally and in writing, with excellent communication skills.
- Good understanding of Global and Country/Regional Clinical Research Guidelines and ability to work within them.
- Hands-on knowledge of Good Documentation Practices.
- Good IT skills, including MS Office and clinical IT applications, and ability to adapt to new applications.
- Strong MS Excel skills.
- ICH-GCP knowledge appropriate to the role.
- Excellent negotiation skills for CTCs in the finance area.
- Effective time management, organizational, interpersonal, and conflict-management skills.
- Able to communicate effectively with external customers, including sites and investigators.
- High accountability and urgency; able to prioritize and handle multiple tasks in a changing environment.
- Able to work effectively in a multicultural matrix environment and maintain culturally sensitive working relationships.
- Commitment to internal and external customer focus.
- Able to work independently and proactively solve problems or propose solutions.
- Positive and growth mindset.
- Completed job training in office management, administration, finance, or healthcare preferred, or a bachelor's degree.
Nice To Haves
- Job training in office management, administration, finance, or healthcare.
Responsibilities
- Provide data-tracking and reporting assistance to teams in Site Management & Monitoring.
- Collate and distribute study tools and documents; update clinical trial databases (CTMS) and trackers.
- Support clinical and non-clinical supply management and manage labeling requirements and translation change requests in collaboration with country roles.
- Prepare correspondence and clinical documents; collate, distribute or ship, and archive documents, including eTMF materials.
- Assist with eTMF reconciliation, execute the eTMF Quality Control Plan, update manuals and study documents, document destruction of clinical supplies, prepare Investigator Trial File binders, and obtain document translations.
- Collect and provide investigator forms and lists for site evaluation, validation, start-up, and submissions; obtain, track, and update study insurance certificates.
- Support preparation of IRB/ERC submission packages and submissions to regulatory agencies.
- Publish study results for Global Clinical Trial Operations and Regulatory Affairs when required by local legislation.
- Collaborate with finance and budgeting representatives to develop, control, update, and close out country and site budgets, including split site budgets.
- Develop, negotiate, approve, and maintain contracts such as CTRAs; track and report contract negotiations; and maintain contract templates with the Legal Department.
- Calculate and execute payments to investigators, vendors, and grants; ensure compliance with financial procedures; monitor adherence and disclosures; maintain tracking tools; and obtain and process FCPA documentation.
- Coordinate meetings and site visits, track and analyze study data, and prepare reports.
- Support local investigator meetings by managing invitations and materials, selecting venues, and supporting vendors where applicable.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, and compassionate and sick days.
- Eligible for annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
