Clinical Trial Coordinator
Clinical Trial Coordinator
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Job Description
Job Description
We are seeking a highly organised and detail-oriented Clinical Trial Coordinator (CTC) to join our team. Reporting to the CTC Manager this role is responsible for ensuring comprehensive trial and site administration including the preparation collation distribution and archiving of clinical documents. The CTC will also support clinical and non-clinical supply management and ensure the timely maintenance of tracking and reporting tools.
Key Responsibilities:
- Track and report essential documents and safety reports
- Collate and distribute study tools and documents
- Update clinical trial databases and trackers
- Manage clinical and non-clinical supply in collaboration with other country roles
- Manage labelling requirements and coordinate translation change requests
- Prepare and archive clinical documents including eTMF
- Assist with eTMF reconciliation and execute quality control plan
- Update manuals and documents
- Coordinate proper destruction of clinical supplies
- Prepare investigator trial file binders
- Obtain translations of documents
- Collaborate with other country roles for regulatory and site start-up responsibilities
- Collaborate with finance/budgeting representatives for budgeting agreement and payments
- Organise and support meetings and local investigator meetings
Required Skills:
- Fluent in local languages and business proficient in English (verbal and written)
- Good understanding of global and country/regional clinical research guidelines
- Knowledge of good documentation practices
- Strong IT skills including MS Office and clinical IT applications
- Familiarity with ICH-GCP guidelines
- Excellent negotiation and communication skills
- Effective time management and organizational skills
- Ability to work independently and handle multiple tasks in a changing environment
- Proactive problem-solving attitude
- Ability to work effectively in a multicultural matrix environment
- Commitment to customer focus
Education and Experience:
- Bachelors degree in a relevant field (Life Sciences Healthcare etc.) is preferred
- Experience in clinical trial coordination or administration preferred
- Knowledge of clinical trial processes and regulations
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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Accountability Accountability Analytical Problem Solving Budget Proposals Clinical Data Management Clinical Documentation Clinical Information Systems Clinical IT Clinical Reporting Clinical Research Clinical Research Coordination Clinical Testing Clinical Trial Compliance Clinical Trial Documentation Clinical Trial Management Clinical Trials Monitoring Clinical Trials Operations Clinical Trial Support Data Analysis Drug Regulatory Affairs ICH GCP Guidelines Management Process Medical Records Management Nursing Project Management 4 morePreferred Skills:
Job Posting End Date:
07/12/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
IC
Employment Type
Full-Time
