Senior Clinical Trial Coordinator

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Deliver thorough trial and site administration while under the guidance of the line manager.

• Prepare, compile, distribute, and archive clinical documentation.

• Provide support for the management of clinical and non-clinical supplies.

• Maintain tracking and reporting tools, as well as clinical trial databases and CTMS.

• Aid in meeting the planned Site Ready dates.

• Assist with the preparation of IRB/ERC and Health Authority submission packages.

• Collaborate with COM, CRM, CRA, finance, and budgeting representatives.

• Oversee labeling requirements and manage translation change requests.

• Prepare, distribute, archive, and ensure quality control of eTMF documents.

• Support eTMF reconciliation and implement the eTMF Quality Control Plan.

• Update manuals and documents, including patient diaries and instructions.

• Prepare Investigator trial file binders and secure document translations.

• Obtain, track, and refresh study insurance certificates.

• Publish study results as mandated by local legislation.

• Develop, manage, update, and close country and site budgets.

• Create, negotiate, approve, and maintain CTRAs and contract templates.

• Monitor contract negotiations and calculate as well as execute payments.

• Ensure compliance with financial and regulatory procedures.

• Oversee disclosures and manage FCPA documentation processes.

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

• Assist with local investigator meetings and related vendors.

• Serve as a Subject Matter Expert, sharing best practices, suggesting improvements, and providing training.

• Mentor and support junior CTCs.

⛳️ Requirements

• At least 3 years of experience in Clinical Research or a related healthcare field.

• Completion of job training (preferably in office management, administration, finance, or healthcare) or a Bachelor’s Degree.

• Proficient 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.

• Advanced skills in MS Excel.

• Knowledge of ICH-GCP relevant to the position.

• Excellent negotiation abilities in the finance area for CTCs.

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

• Effective communication skills with external clients, sites, and investigators.

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

• Ability to operate effectively in a matrix multicultural setting.

• Capacity to work independently and take ownership of assigned tasks.

• Proactive approach to problem-solving.

• Familiarity with Clinical Research.

• Knowledge of Clinical Trial Agreements (CTA).

• Understanding of Clinical Trial Compliance.

• Expertise in Clinical Trial Management.

• Knowledge of Good Clinical Data Management Practice (GCDMP).

• Proficiency in Microsoft Excel.

• Proficiency in Microsoft Office.

• Strong time management skills.

• Experience in Training Delivery.

🏝️ Benefits

• Annual bonus.

• Long-term incentive, if applicable.

• Medical, dental, vision healthcare, and other insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate and sick leave.

• Remote work options available.

• Relocation is not required.