Remote Senior Clinical Trial Coordinator | CTMS

Merck; Hartford (CT); Remote; USD 74,000 - 118,000; Full time

Job summary

Merck & Co., Inc. in the United States seeks a Clinical Trial Coordinator who will manage trial and site administration, document control, budgeting and payments, and regulatory submissions.

The role supports IRB/ERC packages, CTMS updates, and collaboration with COM/CRM/CRA to meet Site Ready dates. The candidate will mentor junior team members, help implement process improvements, and maintain training on GCP, ICH guidelines, and Good Documentation Practices.

Qualifications

• Minimum 3 years in Clinical Research or relevant healthcare experience.
• Completed job training (office management, administration, finance, health care preferred) or Bachelor’s Degree.

Responsibilities

• Track essential documents and report safety reports.
• Ensure collation and distribution of study tools and documents.
• Update clinical trial databases (CTMS) and trackers.
• Clinical supply & non-clinical supply management, in collaboration with other country roles.
• Manage labeling requirements and coordinate translation change requests with other country roles.
• Prepare documents and correspondence.
• Collate, distribute/ship, and archive clinical documents (eTMF).
• Assist with eTMF reconciliation and execute ETMF QC plan.
• Update manuals/documents (patient diaries, instructions).
• Obtain translations of documents.
• Provide site evaluation forms and collect study insurance certificates.
• Support preparation of submission packages for IRB/ERC and regulatory submissions.
• Publish study results for internal stakeholders as required.
• Collaborate with finance for budgets and CTRAs; track negotiations.
• Support local investigator meetings and meeting planning.
• Mentor junior CTCs and share best practices.

Skills

Clinical Trial Management

GCDMP

Time Management

Microsoft Office

Microsoft Excel

ICH-GCP Knowledge

Negotiation skills

Communication skills

Education

Bachelor’s Degree

Tools

CTMS

Microsoft Office

Job description

Merck & Co., Inc. in the United States seeks a Clinical Trial Coordinator who will manage trial and site administration, document control, budgeting and payments, and regulatory submissions.

The role supports IRB/ERC packages, CTMS updates, and collaboration with COM/CRM/CRA to meet Site Ready dates. The candidate will mentor junior team members, help implement process improvements, and maintain training on GCP, ICH guidelines, and Good Documentation Practices.