Senior Clinical Trial Coordinator (Sr. CTC)

MSD•Rahway, NJ

1d•Remote

About The Position

Under the oversight of the line manager, the Senior 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 to help meet planned Site Ready dates, including preparing submission packages for IRB/ERC and Health Authorities. The coordinator collaborates locally with COM, CRM, and CRA roles, and works with finance and budgeting representatives on Clinical Trial Research Agreements (CTRAs) and payments. The role also acts as a process Subject Matter Expert, recommends continuous improvements, provides training, and mentors junior CTCs. Responsibilities span trial and site administration; supply and document management; regulatory and site start-up activities; budgets, agreements, and payments; meeting planning; and quality and oversight.

Requirements

Fluent in local languages and business-proficient in English, verbally and in writing.
At least 3 years of experience in Clinical Research or relevant healthcare experience.
Completed job training (office management, administration, finance, or healthcare preferred) or a bachelor's degree.
Good understanding of global, country, and regional clinical research guidelines, with the ability to work within them.
Hands-on knowledge of Good Documentation Practices.
Good IT skills, including Microsoft Office and clinical IT applications, and the ability to adapt to new IT applications.
Strong Microsoft Excel skills.
ICH-GCP knowledge appropriate to the role.
Excellent negotiation skills for finance-related CTC work.
Highly effective time-management, organizational, and interpersonal skills, including conflict management.
Effective communication with external customers such as sites and investigators.
High sense of accountability and urgency.
Ability to set priorities and handle multiple tasks simultaneously in a changing environment.
Ability to work effectively in a matrix, multicultural environment and establish culturally sensitive working relationships.
Commitment to customer focus, internally and externally.
Ability to work independently and take full ownership of delegated tasks.
Proactive problem-solving approach, including proposing solutions, and a positive, growth-oriented mindset.

Nice To Haves

Clinical Trial Management Systems (CTMS) experience.
Clinical Trials experience.
Leadership.

Responsibilities

Track essential documents and report items such as safety reports.
Collate and distribute study tools and documents, and update clinical trial databases (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 records.
Assist with eTMF reconciliation and execute the eTMF Quality Control Plan.
Update manuals and documents, including 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 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 when 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; and maintain contract templates with the Legal Department.
Calculate and execute payments to investigators, vendors, and grants; ensure compliance with financial and compliance procedures; and 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.
Act as a process Subject Matter Expert, share best practices, recommend continuous improvements, and provide training as appropriate or required.
Mentor or buddy junior CTCs, including on process requirements.