Job Description
Under the oversight of the line-manager, the Clinical Trial Coordinator (CTC) role is responsible for comprehensive trial and site administration and involves preparing, collating, distributing and archiving clinical documents. The CTC also supports and ensures timely maintenance of tracking and reporting tools, as applicable.
The role is critical and has a key role to meet planned Site Ready dates, including collaborating with finance/budgeting representatives to manage contracts and payments. This role will collaborate at local level closely with Clinical Operations Managers (COM), Clinical Research Managers (CRM), Clinical Research Associates (CRA) and other areas such regulatory and logistics.
Responsibilities include, but are not limited to:
- Trial and site administration: o Track (e.g. essential documents) and reports
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
Update manuals/documents (e.g., patient diaries, instructions)
In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
- 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
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/compliance documentation in a timely manner
Required skills:
- Fluent 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 IT skills (Use of MS office, use of some clinical IT applications on computer) and ability to adapt to new IT applications. Strong MS Excel skills required.
- Excellent negotiation skills for CTCs in finance area
- Effective time management, organizational and interpersonal skills, conflict management
- Effective communication with external customers (e.g. sites and investigators)
- 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
- Proactive attitude to solving problems / proposing solutions
- Positive mindset, growth mindset
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:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
noRequired Skills:
Accountability, Accountability, Analytical Problem Solving, Clinical Data Management, Clinical Information Systems, Clinical IT, Clinical Research, Clinical Risk Management, Clinical Sciences, Clinical Site Management, Clinical Testing, Clinical Trial Compliance, Clinical Trial Documentation, Clinical Trial Management, Clinical Trials Monitoring, Clinical Trials Operations, Clinical Trial Support, Contract Lifecycle Management (CLM), Contract Management, Customer Communications, Data Analysis, Drug Regulatory Affairs, ICH GCP Guidelines, Management Process, Nursing {+ 3 more}Preferred Skills:
Job Posting End Date:
08/14/2025- A job posting is effective until 11:59:59PM 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:R360968