Clinical Trial Coordinator - Monitoring (Remote)

Merck • Rahway, NJ

2d • $68,000 - $107,000 • Remote

About The Position

Under the oversight of the line-manager, the Clinical Trial Coordinator-Monitoring (CTC-M) 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 ensures timely maintenance of tracking and reporting tools. It is critical to meeting planned Site Ready dates, including assisting with IRB/ERC and Health Authority submission packages. The CTC-M collaborates locally with Clinical Operations Managers, Clinical Research Managers, Clinical Research Associates, finance and budgeting representatives, and other country roles to support site operations, agreements, and payments.

The position also supports regulatory and site start-up activities, document quality and reconciliation, budget and contract administration, compliance tracking, and local investigator meeting planning. The role is remote, has a stated travel requirement of 10%, and requires business-proficient English, local-language fluency, strong organization and communication skills, and relevant job training or a bachelor’s degree.

Requirements

• Fluency in local languages and business proficiency in English, both verbal and written.
• Excellent communication skills.
• 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 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.
• Ability to communicate effectively with external customers, including sites and investigators.
• High accountability and urgency; ability to set priorities and handle multiple tasks simultaneously in a changing environment.
• Ability to work effectively in a multicultural matrix environment and establish culturally sensitive working relationships.
• Commitment to customer focus, internally and externally.
• 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

• Preferred skills include clinical data management, clinical documentation and document management, clinical trial compliance, clinical trial management, clinical trials monitoring and operations, clinical trial support, and drug regulatory affairs.

Responsibilities

• Provide expert assistance with data tracking and reporting tasks for teams within the Site Management & Monitoring organization.
• Collate and distribute study tools and documents.
• Update clinical trial databases (CTMS) and trackers.
• Support clinical and non-clinical supply management 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 records.
• 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.
• Work with country roles to provide and collect forms and lists for site evaluation, validation, start-up, and submissions.
• Obtain, track, and update study insurance certificates.
• Support preparation of IRB/ERC submission packages and submissions to regulatory agencies.
• Publish study results for Global Clinical Trial Operations and Regulatory Affairs when required by local legislation.
• Work 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.
• Coordinate meetings and site visits; track, manage, and analyze study data; and prepare reports.
• Support local investigator meetings by managing invitations, preparing materials, selecting venues, and supporting vendors where applicable.

Benefits

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

What This Job Offers

• Job Type: Full-time