Remote Clinical Trial Monitoring Coordinator

Merck & Co.; United States; Remote; USD 68.000 - 107.000; Vollzeit

Benefits dieser Stelle

Medical, dental, vision coverage

401(k) retirement plan

Paid holidays

Vacation

Compassionate and sick days

Zusammenfassung

Merck & Co., Inc. in Rahway, NJ, USA seeks a Clinical Trial Coordinator-Monitoring (CTC-M) to support trial and site administration, data tracking, and regulatory submissions. You will collaborate with COM, CRM, CRA, and finance to manage CTRAs and payments.

Proficiency in English, GCP guidelines, and documentation practices is essential. The role involves updating CTMS, coordinating study tools, handling labeling and translation requests, and assisting with eTMF reconciliation.

Qualifikationen

• Fluent in Local Languages and English with strong communication.
• Good understanding of Global/Regional Clinical Research Guidelines.
• Hands on knowledge of Good Documentation Practices.
• Strong IT skills (MS Office) and ability to adapt to new IT applications.
• ICH-GCP knowledge appropriate to role.
• Excellent negotiation skills for CTMs in finance area.

Aufgaben

• Provide expert trial and site administration support and data tracking/reporting tasks.
• Update clinical trial databases (CTMS) and trackers and distribute study tools/documents.
• Manage labeling requirements and translation change requests.
• Prepare Investigator trial file binders and archive clinical documents (eTMF).
• Support regulatory submissions to IRB/ERC and health authorities; CTRAs and payments.

Kenntnisse

English proficiency

MS Excel

ICH-GCP knowledge

Data tracking

Negotiation

Project management

Ausbildung

Bachelor's degree

Tools

CTMS

eTMF

MS Office

Jobbeschreibung

Merck & Co., Inc. in Rahway, NJ, USA seeks a Clinical Trial Coordinator-Monitoring (CTC-M) to support trial and site administration, data tracking, and regulatory submissions. You will collaborate with COM, CRM, CRA, and finance to manage CTRAs and payments.

Proficiency in English, GCP guidelines, and documentation practices is essential. The role involves updating CTMS, coordinating study tools, handling labeling and translation requests, and assisting with eTMF reconciliation.