Clinical Trial Coordinator – FSP

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

📋 Description

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

• Monitor critical documents and report on safety findings.

• Gather and distribute study-related tools and documents.

• Update clinical trial management systems (CTMS) and tracking tools.

• Coordinate the management of clinical and non-clinical supplies in partnership with country-specific roles.

• Oversee labeling requirements and manage translation change requests.

• Prepare, distribute, ship, archive, and conduct quality control on clinical documents.

• Assist with the reconciliation of the electronic Trial Master File (eTMF) and implement the eTMF Quality Control Plan.

• Create Investigator Trial File binders and revise manuals and documents.

• Secure translations and document the proper disposal of clinical supplies.

• Provide and collect investigator forms/lists for site assessment, validation, initiation, and submissions.

• Acquire, track, and update study insurance certificates.

• Aid in the preparation of IRB/Ethics Review Committee submission packages and regulatory agency submissions.

• Publish study results as mandated by local legislation.

• Collaborate with finance/budgeting representatives on country and site budgets, negotiations, tracking tools, contracts, payments, financial compliance, disclosures, and budget closures.

• Obtain and process documentation related to the Foreign Corrupt Practices Act.

• Organize meetings and prepare study memos, letters, and protocols.

• Support local investigator meetings, including managing invitations, materials, venue selection, and logistics.

• Complete required Client and Parexel training while adhering to SOPs and established processes.

• Enhance team knowledge by mentoring and sharing best practices.

⛳️ Requirements

• B.A./B.S. (Life Sciences preferred) or equivalent experience in healthcare.

• At least 1-2 years of experience in Clinical Research or relevant healthcare roles.

• Strong understanding of Global, Country/Regional Clinical Research Guidelines and the ability to operate within these frameworks.

• Practical knowledge of Good Documentation Practices.

• Proficient IT skills, including MS Office and clinical IT applications; strong MS Excel skills are essential.

• Knowledge of International Committee on Harmonization (ICH) Good Clinical Practice (GCP) relevant to the role.

• Strong skills in time management, organization, interpersonal relations, and conflict resolution.

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

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

• Capacity to work effectively in a multicultural matrix environment and foster culturally sensitive relationships.

• Ability to work autonomously.

• Proactive approach to problem-solving and proposing solutions.

• Fluency in local languages and business proficiency in English, both verbal and written.

• Excellent communication skills.

🏝️ Benefits

• Competitive salary and performance-related bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Supportive work environment that encourages collaboration and innovation.