Clinical Trial Coordinator-Regulatory (CTC-R)

Job Description

Under the oversight of the line-manager this role is responsible for comprehensive trial and siteadministration and involves preparing collating distributing and archiving clinical documents. TheCTC supports clinical supply & non-clinical supply management and ensures timely maintenanceof tracking and reporting tools as applicable.
The role is critical to meet planned Site Ready dates including assisting with the preparation ofsubmission packages to IRB/ERC and Health Authorities. The role will collaborate at local levelclosely with COM CRM and CRA.
Responsibilities include but are not limited to:

Trial and site administration:
o Track (e.g. essential documents) and report (e.g. Safety Reports)
o Ensure collation and distribution of study tools and documents
o Update clinical trial databases (CTMS) and trackers
o Clinical supply & non-clinical supply management in collaboration with other country
roles
o Manage Labeling requirements and coordinate/sign translation change request in
collaboration with other country roles (if applicable)
Document management:
o Prepare documents and correspondence
o Collate distribute/ship and archive clinical documents e.g. eTMF
o Assist with eTMF reconciliation
o Execute eTMF Quality Control Plan
o Update manuals/documents (e.g. patient diaries instructions)
o Document proper destruction of clinical supplies.
o Prepare Investigator trial file binders
o Obtain translations of documents
Regulatory & Site Start-Up responsibilities: Collaborate with other country roles to:
o In a timely manner provide to and collect from investigators forms/lists for site
evaluation/validation site start-up and submissions
o Obtain track and update study insurance certificates
o Support preparation of submission package for IRB/ERC and support regulatory
agencies submissions.
o Publish study results for GCTO and RA where required per local legislation
Budgeting Agreement and Payments:
Collaborate with finance/budgeting representatives for:
o Develop control update and close-out country and site budgets (including Split site
budget)
o Develop negotiate approve and maintain contracts (e.g. CTRAs)
o Track and report contract negotiations
o Update and maintain contract templates (in cooperation with Legal Department)
o Calculate and execute payments (to investigators vendors grants)
o Ensure adherence to financial and compliance procedures
o Monitor and track adherence and disclosures
o Maintain tracking tools
o Obtain and process FCPA documentation in a timely manner

Meeting Planning:
o Organize meetings (create & track study memos/letters/protocols)
o Support local investigator meetings (invitations prepare materials select venue
support vendor where applicable)

o collaborates with finance/budgetingrepresentatives to manage CTRAs and payments.

Required Skills:

Preferred Skills:

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Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

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