Clinical Trial Coordinator (CTC) - REMOTE

Merck & Co. • Rahway, NJ

437d • Onsite

About The Position

The Clinical Trial Coordinator (CTC) plays a vital role in the Clinical Research and Pharmacovigilance team, responsible for comprehensive trial and site administration. This position ensures the safety and efficacy of products through clinical trials and surveillance, supporting clinical supply management and maintaining tracking and reporting tools. The CTC collaborates closely with various roles to meet planned Site Ready dates and assists in preparing submission packages for regulatory bodies.

Requirements

• 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
• Strong IT skills, including MS Office and clinical IT applications
• Strong MS Excel skills
• Knowledge of ICH-GCP appropriate to role
• Excellent negotiation skills in finance area
• Effective time management and organizational skills
• Ability to handle multiple tasks in a changing environment
• Ability to establish and maintain culturally sensitive working relationships
• Proactive attitude to problem-solving

Nice To Haves

• Bachelor's Degree preferred

Responsibilities

• Track essential documents and report safety reports
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Manage clinical and non-clinical supply management in collaboration with other country roles
• Coordinate labeling requirements and translation change requests
• Prepare and manage clinical documents and correspondence
• Assist with eTMF reconciliation and execute eTMF Quality Control Plan
• Update manuals and documents such as patient diaries and instructions
• Document proper destruction of clinical supplies
• Collaborate with country roles for site evaluation and validation
• Obtain and track study insurance certificates
• Support preparation of submission packages for IRB/ERC and regulatory agencies
• Publish study results as required by local legislation

Benefits

• Flexible work arrangements (remote)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED