MSD Clinical Trial Coordinator Intern 

Israel, Center District 

670992842

Job Description

This program provides comprehensive trial and site administration experience. Under the oversight of the Sr.COM/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.

During this program you will learn and experience the following, but are not limited

• 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:

·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

·B.A./B.S. (Life Science preferred) or equivalent healthcare experience.

·GCP course/ CRA course

*Internship duration – up to 12 months

Current Contingent Workers apply

Intern/Co-op (Fixed Term)

Not Applicable

Hazardous Material(s):

Job Posting End Date:05/12/2024

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