Clinical Trial Coordinator (CTC) - Remote

Merck • Rahway, NJ

3d • $68,000 - $107,000 • Remote

About The Position

Under the oversight of the line manager, the Clinical Trial Coordinator 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, including assisting with IRB/ERC and Health Authority submission packages. The coordinator collaborates locally with COM, CRM, and CRA roles and works with finance and budgeting representatives on CTRAs and payments.

The position also supports document management, regulatory and site start-up activities, budgeting, agreements and payments, and meeting planning. It is a remote role with 10% travel. The listed salary range is $68,000–$107,000, and the successful candidate may be eligible for an annual bonus and long-term incentive, if applicable.

Requirements

• Fluency in local languages and business proficiency in English, both verbal and written.
• Excellent communication skills, including effective communication with external customers such as sites and investigators.
• 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 Microsoft Office and clinical IT applications, and ability to adapt to new IT applications.
• Strong Microsoft 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.
• High accountability and urgency; ability to prioritize and handle multiple tasks simultaneously in a changing environment.
• Ability to work effectively in a matrix multicultural environment and establish and maintain culturally sensitive working relationships.
• Commitment to internal and external customer focus.
• Ability to work independently and proactively solve problems or propose solutions.
• Positive and growth mindset.
• Completed job training, preferably in office management, administration, finance, or health care, or a bachelor's degree.

Nice To Haves

• Experience or familiarity with Clinical Trial Management Systems (CTMS).
• Clinical Trials knowledge.
• Communication skills.

Responsibilities

• Track essential documents and report items such as Safety Reports.
• Collate and distribute study tools and documents.
• Update clinical trial databases, including CTMS, and trackers.
• Manage clinical and non-clinical supplies in collaboration with other country roles.
• Manage labeling requirements and coordinate or sign translation change requests, where applicable.
• Prepare documents and correspondence; collate, distribute or ship, and archive clinical documents, including eTMF materials.
• Assist with eTMF reconciliation and execute the eTMF Quality Control Plan.
• Update manuals and documents, such as patient diaries and instructions.
• Document proper destruction of clinical supplies.
• Prepare Investigator Trial File binders and obtain document translations.
• Provide and collect forms and lists from investigators for site evaluation, validation, start-up, and submissions in a timely manner.
• Obtain, track, and update study insurance certificates.
• Support preparation of IRB/ERC submission packages and submissions to regulatory agencies.
• Publish study results for GCTO and RA where 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.
• Update and maintain contract templates in cooperation with the Legal Department.
• Calculate and execute payments to investigators, vendors, and grants.
• Ensure adherence to financial and compliance procedures; monitor and track adherence and disclosures.
• Maintain tracking tools and obtain and process FCPA documentation in a timely manner.
• Organize meetings and create and track study memos, letters, and protocols.
• Support local investigator meetings, including invitations, materials, venue selection, and vendor support where applicable.

Benefits

• Medical, dental, and vision healthcare and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Annual bonus and long-term incentive eligibility, if applicable.

What This Job Offers

• Job Type: Full-time