Clinical Trial Coordinator Intern

This program provides comprehensive trial and site administration experience. Under the oversight of the COM Lead/COMs and CTCs the person prepares collates distributes and archives clinical documents. The Interns supports clinical supply & nonclinical 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 & nonclinical 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 StartUp responsibilities: Collaborate with other country roles to:

  • In a timely manner provide to and collect from investigators forms/lists for site evaluation/validation site startup 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