Clinical Trial Coordinator

Job Description
Under the oversight of the line-manager, this role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

The role is critical to meeting planned Site Ready dates, including assisting finance/budgeting representatives in managing CTRAs and payments. The role will collaborate closely at the local level with COM, CRM, and CRA.

Responsibilities Include, But Are Not Limited To

• Trial and site administration
• Track (e.g. essential documents)
• Ensure collation and distribution of study tools and documents
• Update clinical trial databases (CTMS) and trackers
• Document management
• Prepare documents and correspondence
• Collate, distribute/ship, and archive clinical documents, e.g. eTMF
• Assist with eTMF reconciliation
• Execute eTMF Quality Control Plan
• Prepare Investigator trial file binders
• Obtain translations of documents
• Budgeting, Agreement and Payments

Collaborate with finance/budgeting representatives for

• Develop, control, update and close-out country and site budgets (including Split site budget)
• Develop, negotiate, approve and maintain contracts (e.g. CTRAs)
• Track and report contract negotiations
• Update and maintain contract templates (in cooperation with Legal Department)
• Calculate and execute payments (to investigators, vendors, grants)
• Ensure adherence to financial and compliance procedures
• Monitor and track adherence and disclosures
• Maintain tracking tools
• Obtain and process FCPA documentation in a timely manner

Main Requirements

• Bachelor's Degree;
• Fluent in Portuguese and business proficient in English (verbal and written) and excellent communication skills;
• Good understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines;
• Hands on knowledge of Good Documentation Practices;
• Good Information Technology skills. Strong Microsoft Excel skills required;
• International Conference on Harmonisation Good Clinical Practice Knowledge appropriate to role;
• Excellent negotiation skills;
• Effective time management, organizational and interpersonal skills, conflict management;
• Effective communication with external customers;
• High sense of accountability / urgency. Ability to set priorities and handle multiple tasks simultaneously in a changing environment;
• Works effectively in a matrix multicultural environment. Ability to establish and maintain culturally sensitive working relationships;
• Demonstrates commitment to Customer focus, both internally and externally;
• Able to work independently.

Required Skills
Accountability, Analytical Problem Solving, Clinical Information Systems, Clinical Site Management, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trials, Clinical Trials Monitoring, Clinical Trials Operations, Clinical Trial Support, Contract Management, Contract Negotiations, Data Analysis, Document Management, Project Management, Regulatory Compliance, Supply Management

Preferred Skills
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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
No relocation

VISA Sponsorship
No

Travel Requirements
No Travel Required

Flexible Work Arrangements
Hybrid

Shift
Not Indicated

Valid Driving License
No

Hazardous Material(s)
no

Job Posting End Date
11/11/2025

• A job posting is effective until PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID
R371532