Job Description
CTC Intern
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 Overview
Internship duration – up to 12 months, full-time position.
During this program you will learn and experience the following, but are not limited to:
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
Office-based - Hod Hasharon.
CORE Competency Expectations
•Fluent in Local Languages and business proficient in English (verbal and written) and excellent communication skills.
Behavioral Competency Expectations
•Effective time management, organizational and interpersonal skills, conflict management
Educational Requirements
•B.A./B.S. (Life Science preferred) or equivalent healthcare experience.
•GCP course/ CRA course
Required Skills
Ability to Coordinate, Audit Trails, Clinical Databases, Clinical Research, Clinical Supplies Management, Cloud Data Catalog, Conflict Management, Data Analysis, Database Management, Data Destruction, Data Science, Data Security, Data Visualization, Data Wrangling, Detail-Oriented, Documentation Maintenance, Document Management, Document Management Software, Evaluating Applications, Event Planning, Financial Tracking, Healthcare Databases, Insurance Coverage, Insurance Policies (+9 more)
Employment Details
•Employee Status: Intern/Co-op (Fixed Term)
•Flexible Work Arrangements: Not Applicable
