Clinical Trial Coordinator Intern

Job Description

The internship program provides learning experience, mentoring and valuable work experience in the field of clinical trials. We provide our interns the opportunity to work on meaningful assignments and make sure that they gain real world experiences (in the areas of Regulatory & Finance and Supply & CRA support).

 

This program provides comprehensive trial and site administration experience. Under the oversight of the COM Lead/COMs and CTC’s, the person prepares, collates, distributes and archives clinical documents. The Interns supports clinical supply & non-clinical supply management and ensures timely maintenance of tracking and reporting tools, as applicable.

 

* Internship duration – up to 12 months *  

 

Responsibilities:

• Trial and site administration:
  • Track (e.g. essential documents) and report (e.g. Safety Reports)
  • Ensure collation and distribution of study tools and documents
  • Update clinical trial databases (CTMS) and trackers
  • Clinical supply & non-clinical supply management, in collaboration with other country roles
  • Manage Labeling requirements and coordinate/sign translation change request
• 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)
  • Document proper destruction of clinical supplies.
  • Prepare Investigator trial file binders
  • Obtain translations of documents
• Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
  • In a timely manner, provide to and collect from investigators forms/lists for site evaluation/validation, site start-up and submissions
  • Obtain, track and update study insurance certificates
  • Support preparation of submission package for IRB/ERC and support regulatory agencies submissions.
  • Publish study results for GCTO and RA where required per local legislation

Requirements:

• B.A./B.S. (Life Science preferred) or equivalent healthcare experience.
• Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills.
• Effective time management, organizational and interpersonal skills, conflict management

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Current Contingent Workers apply HERE

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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:

Intern/Co-op (Fixed Term)

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Biopharmaceutics, Biopharmaceutics, Clinical Information Systems, Clinical Research, Clinical Testing, Clinical Trial Documentation, Cloud Data Catalog, Data Analysis, Database Management, Data Science, Data Security, Data Visualization, Data Wrangling, Detail-Oriented, Emergency Care, Event Planning, Key Performance Indicators (KPI), Medical Supply Management, Nursing, Project Management, Python (Programming Language), Quality Management, Regulatory Compliance, Regulatory Reviews, Site Initiation {+ 5 more}

 Preferred Skills:

Job Posting End Date:

06/19/2025

*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.