Clinical Trial Operations Coordinator - Remote

Regulatory Jobs; United States; Remote; USD 68,000 - 107,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k)

Paid holidays, vacation, sick days

Job summary

Merck & Co., Inc., Rahway, NJ, USA is seeking a Clinical Trial Coordinator-Monitoring (CTC-M) to oversee trial and site administration, support regulatory submissions, and manage document control. The role includes collaboration with COM, CRM, CRA, and finance teams to manage CTRAs and payments.

Responsibilities cover data tracking, CTMS updates, labeling, translation requests, budget development, and site start-up support. Remote work is available with travel up to 10%.

Qualifications

• Fluent in Local Languages and business proficient in English (verbal and written)
• Good understanding of Global, Country/Regional Clinical Research Guidelines
• Hands on knowledge of Good Documentation Practices
• ICH-GCP Knowledge appropriate to role
• Excellent negotiation skills for CTCs in finance area
• Effective time management and organizational skills
• Ability to work independently in a matrix multicultural environment

Responsibilities

• Provide expert assistance with data tracking and reporting tasks to various teams
• Update clinical trial databases (CTMS) and trackers
• Collaborate with country roles for site start-up and submissions
• Prepare Investigator trial file binders and translations of documents
• Develop and maintain budgets and CTRAs
• Support preparation of submission packages for IRB/ERC and regulatory agencies
• Plan and support investigator meetings

Skills

Data Analysis

Site Management

Regulatory Submissions

Document Management

MS Excel

Project Management

Time Management

Communication

Education

Bachelor’s degree

Office management training

Tools

MS Office

Job description

Merck & Co., Inc., Rahway, NJ, USA is seeking a Clinical Trial Coordinator-Monitoring (CTC-M) to oversee trial and site administration, support regulatory submissions, and manage document control. The role includes collaboration with COM, CRM, CRA, and finance teams to manage CTRAs and payments.

Responsibilities cover data tracking, CTMS updates, labeling, translation requests, budget development, and site start-up support. Remote work is available with travel up to 10%.