Clinical Trial Coordinator – FSP

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

📋 Description

• Assist the Clinical Research Manager and team members throughout the entire study lifecycle, from initiation to closure.

• Monitor essential documents and report on safety issues.

• Gather and distribute study tools and documentation.

• Update databases and trackers related to clinical trials.

• Collaborate with country roles to manage both clinical and non-clinical supplies.

• Oversee labeling requirements and coordinate/sign requests for translation changes.

• Prepare, gather, distribute, ship, and archive clinical documents and correspondence.

• Support the reconciliation of the electronic Trial Master File and implement the Quality Control Plan for it.

• Revise manuals and documents, as well as obtain necessary translations.

• Document the proper disposal of clinical supplies.

• Compile Investigator trial file binders.

• Provide and collect forms/lists from investigators for site evaluation, validation, initiation, and submissions.

• Acquire, monitor, and update study insurance certificates.

• Assist with submissions to the Institutional Review Board/Ethics Review Committee and regulatory agencies.

• Publish study results as mandated by local legislation.

• Create budgets for countries and sites while tracking negotiations.

• Maintain tracking tools and contract templates.

• Assist in the development, negotiation, approval, and upkeep of contracts.

• Calculate and process payments for investigators, vendors, and grants.

• Ensure adherence to financial procedures and track compliance and disclosures.

• Complete budget closeout and manage Foreign Corrupt Practices Act documentation.

• Organize and support local investigator meetings.

• Complete necessary training, timesheets, expense reports, and updates to CVs.

• Ensure compliance with Parexel processes, ICH-GCP, and relevant requirements.

• Enhance team knowledge by mentoring and sharing best practices.

⛳️ Requirements

• Candidates should possess 1-2 years of experience in clinical research.

• Proficiency in local languages and business-level English (both verbal and written).

• Solid understanding of Global and Country/Regional Clinical Research Guidelines.

• Practical knowledge of Good Documentation Practices.

• Strong IT skills, including proficiency in MS Office and clinical IT applications.

• Excellent skills in MS Excel.

• Knowledge of International Council for Harmonization – Good Clinical Practice relevant to this role.

• Strong time management, organizational, interpersonal, and conflict resolution skills.

• Effective communication abilities with external stakeholders, including sites and investigators.

• Capability to prioritize tasks and manage multiple responsibilities simultaneously in a dynamic environment.

• Ability to work effectively in a matrix multicultural environment while maintaining culturally sensitive relationships.

• Independent work capability.

• Proactive approach to problem-solving and proposing solutions.

• Bachelor’s degree in Life Sciences preferred, or equivalent healthcare experience.

🏝️ Benefits

• Comprehensive health benefits.

• Opportunities for professional development and career growth.

• Supportive work environment with a focus on teamwork and collaboration.

• Competitive salary and performance-based bonuses.