Clinical Trial Coordinator (CTC)

MSD•Rahway, NJ

1d•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 in a timely manner. It contributes to planned Site Ready dates, including by assisting with submission packages to IRB/ERC and Health Authorities. The coordinator collaborates locally with COM, CRM, CRA, and finance and budgeting representatives to manage clinical trial agreements and payments. The role also supports regulatory and site start-up activities, document and eTMF management, country and site budgeting, contract administration, investigator payments, and meeting planning. It requires effective communication with investigators and sites, careful adherence to clinical research, documentation, financial, and compliance requirements, and the ability to work independently in a changing, multicultural matrix environment.

Requirements

Fluent in local languages and business proficient in English, verbally and in writing.
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 sense of 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 customer focus, internally and externally.
Ability to work independently and proactively solve problems or propose solutions.
Positive and growth mindset.
Completed job training in office management, administration, finance, or healthcare preferred, or a Bachelor's Degree.

Nice To Haves

Completed job training in office management, administration, finance, or healthcare.
Clinical Trial Management Systems (CTMS) skills.
Clinical trials experience.
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 tracking tools.
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 materials.
Assist with eTMF reconciliation, execute the eTMF Quality Control Plan, and 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 to and collect from investigators forms and lists for site evaluation or validation, site 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 GCTO and RA where required by local legislation.
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; and maintain contract templates 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 by managing invitations and materials, selecting venues, and supporting vendors where applicable.