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 & 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.
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.
