Clinical Trial Coordinator (CTC) - REMOTE

Merck KGaA Darmstadt Germany - Trenton, NJ

Full-time - Entry Level

Remote - Trenton, NJ

Chemical Manufacturing

About the position

The Clinical Trial Coordinator (CTC) at Merck is responsible for comprehensive trial and site administration, ensuring the safety and efficacy of clinical trials. This role involves preparing, collating, distributing, and archiving clinical documents, supporting clinical supply management, and maintaining tracking and reporting tools. The CTC collaborates closely with various stakeholders to meet planned Site Ready dates and assists with submission packages to regulatory bodies.

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
• Coordinate labeling requirements and translation change requests
• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents (e.g., eTMF)
• Assist with eTMF reconciliation and execute Quality Control Plan
• Update manuals/documents (e.g., patient diaries, instructions)
• Document proper destruction of clinical supplies
• Prepare Investigator trial file binders
• Obtain translations of documents
• Provide and collect forms/lists for site evaluation/validation
• Obtain, track, and update study insurance certificates
• Support preparation of submission package for IRB/ERC and regulatory agencies
• Publish study results for GCTO and RA as required

Requirements

• High School Diploma or equivalent with completed job training (office management, administration, finance, healthcare preferred) required
• Bachelor's Degree preferred
• 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
• Good IT skills, including strong MS Excel skills
• Knowledge of ICH-GCP appropriate to role
• Excellent negotiation skills in finance area
• Effective time management, organizational, and interpersonal skills
• Ability to work independently and proactively solve problems
• Ability to establish and maintain culturally sensitive working relationships

Nice-to-haves

• Experience in clinical research or trial coordination
• Familiarity with clinical IT applications
• Experience in a multicultural environment

Benefits

• Health insurance
• 401k plan
• Paid time off
• Flexible scheduling