Clinical Trial Coordinator – Regulatory

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

📋 Description

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

• Monitor essential documentation and report safety data.

• Gather and disseminate study tools and documentation.

• Update clinical trial databases and tracking systems.

• Oversee both clinical and non-clinical supplies in collaboration with country roles.

• Manage labeling requirements and requests for translation changes.

• Prepare, distribute, ship, archive, and ensure the quality of clinical documents.

• Aid in the reconciliation of the electronic Trial Master File.

• Create investigator trial file binders.

• Obtain translations for necessary documents.

• Provide and gather investigator forms required for site evaluation, initiation, and submissions.

• Monitor study insurance certificates.

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

• Publish study findings as mandated by local laws.

• Develop and monitor budgets for countries and sites, including negotiations.

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

• Calculate and process payments for investigators, vendors, and grant recipients.

• Ensure financial compliance, disclosures, and budget closure.

• Manage documentation related to the Foreign Corrupt Practices Act.

• Organize study meetings and support local investigator meetings.

• Complete necessary training, timesheets, expense reports, and CV updates.

• Adhere to Parexel procedures, ICH-GCP, and relevant regulations.

⛳️ Requirements

• 1–2 years of experience in clinical research or a related healthcare field.

• Bachelor’s degree (preferably in Life Sciences) or equivalent healthcare experience.

• Proficient in local languages.

• Business-level proficiency in English, both spoken and written.

• Strong understanding of global and country/regional clinical research regulations.

• Practical knowledge of Good Documentation Practices.

• Proficient IT skills, including Microsoft Office and clinical IT applications.

• Strong skills in Microsoft Excel.

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

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

• Capability to work independently while managing multiple responsibilities.

• Ability to thrive in a multicultural, matrix environment.

• Skill in establishing culturally sensitive working relationships.

• Proactive approach to problem-solving.

• Willingness to act as a mentor and share best practices.

🏝️ Benefits

• Equal opportunity in employment.

• Comprehensive training curriculum.

• Support for professional compliance and development.

• Flexible arrangements for remote work.