Remote Clinical Trial Coordinator: Docs & Start-Up

Merck; Hartford (CT); Remote; USD 68,000 - 107,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k)

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Inc. is seeking a Clinical Trial Coordinator to oversee trial and site administration, manage essential documents, and support regulatory submissions.

The role collaborates with COM, CRM, and CRA, while coordinating with finance for CTRAs and payments, ensuring timely IRB/ERC submissions, and maintaining CTMS data accuracy. The position requires a Bachelor’s Degree or equivalent training, strong Excel skills, and the ability to work in a remote-flexible environment with a focus on

Qualifications

• Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree.

Responsibilities

• Track and report essential documents (e.g., Safety Reports).
• Ensure collation and distribution of study tools and documents.
• Update clinical trial databases (CTMS) and trackers.
• Clinical supply and non-clinical supply management, in collaboration with other country roles.
• Manage labeling requirements and coordinate translational change requests with country roles (if applicable).
• Prepare documents and correspondence.
• Collate, distribute/ship, and archive clinical documents (eTMF).
• Assist with eTMF reconciliation.
• Execute eTMF Quality Control Plan.
• Update manuals/documents (e.g., patient diaries, instructions).
• Obtain translations of documents.
• Provide forms/lists for site evaluation/validation and site start-up.
• Obtain, track and update study insurance certificates.
• Support preparation of submission packages for IRB/ERC and regulatory submissions.
• Publish study results for GCTO and RA as required by local legislation.
• Develop, control, update and close-out country and site budgets (including Split site budget).
• Develop, negotiate, approve and maintain contracts (e.g., CTRAs).
• Track and report contract negotiations.
• Update and maintain contract templates (with Legal Department).
• Calculate and execute payments (to investigators, vendors, grants).
• Ensure adherence to financial and compliance procedures.
• Monitor and track adherence and disclosures.
• Maintain tracking tools.
• Obtain and process FCPA documentation timely.
• Organize meetings (create and track study memos/letters/protocols).
• Support local investigator meetings (invitations, prepare materials, venue, vendor support).

Skills

Clinical Document Management

Clinical Research

Clinical Trial Documentation

Clinical Trial Management

Clinical Trials Monitoring

Clinical Trials Operations

Clinical Trial Support

Customer-Focused

Microsoft Excel

Microsoft Office

Education

Bachelor’s Degree

Tools

CTMS

Job description

Merck & Co., Inc. is seeking a Clinical Trial Coordinator to oversee trial and site administration, manage essential documents, and support regulatory submissions.

The role collaborates with COM, CRM, and CRA, while coordinating with finance for CTRAs and payments, ensuring timely IRB/ERC submissions, and maintaining CTMS data accuracy. The position requires a Bachelor’s Degree or equivalent training, strong Excel skills, and the ability to work in a remote-flexible environment with a focus on