Job Description

Join Our Team as a Clinical Trial Coordinator (CTC)!

The Clinical Trial Coordinator (CTC) plays a vital role in the comprehensive administration of clinical trials and site operations. Under the guidance of the Line Manager, you will be responsible for preparing, collating, distributing, and archiving essential clinical documents. In this role, you will support both clinical and non-clinical supply management while ensuring the timely maintenance of tracking and reporting tools.

Your contributions will be critical in meeting planned Site Ready dates, including assisting with the preparation of submission packages for Ethical Review Committees (ERC) and Health Authorities (HA). Collaboration will be key, as you work closely with the Clinical Operations Manager (COM), Clinical Research Manager (CRM), and Clinical Research Associate (CRA) at the local level. Additionally, you will partner with finance and budgeting representatives to efficiently manage contracts and payments.

What You’ll Do:

As a Clinical Trial Coordinator, your responsibilities will include, but are not limited to:

• Trial and Site Administration:
  • Track essential documents and report on key metrics (e.g., Safety Reports) to ensure compliance and readiness.
  • Ensure timely collation and distribution of study tools, documents, and updates in clinical trial databases (e.g., CTMS).
  • Collaborate with local teams to manage clinical and non-clinical supply logistics, ensuring smooth operations.
• Document Management:
  • Prepare and maintain essential documentation and correspondence, including eTMF setup.
  • Assist with eTMF reconciliation and execute the eTMF Quality Control Plan to uphold the highest standards.
  • Update manuals and documents (e.g., patient diaries, instructions) to ensure clarity and compliance.
• Regulatory & Site Start-Up Responsibilities:
  • Coordinate the collection of necessary forms from investigators for site evaluation and validation.
  • Track and update study insurance certificates, ensuring compliance with regulations.
  • Support the preparation of submission packages for IRB/ERC, facilitating timely approval from regulatory agencies.

What We’re Looking For:

• A Bachelor’s Degree (Health care background preferred)
• At least 1 year of experience in Clinical Operations
• Fluency in local languages and business proficiency in English (verbal and written)
• Excellent communication skills, with a knack for collaboration and problem-solving

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

04/25/2025

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