0983 Clinical Trial Assistant
The Clinical Trial Assistant can be partly or fully responsible for the following areas depending on their level of proficiency.
Create/maintain essential document trackers.
Conduct comprehensive Trial Master File (TMF) review.
Provide continuous input to TMF content list.
Assist with Clinical Operations (Clin Ops) internal electronic filing of study documents.
Facilitate the initiation & maintenance of the clinical trial agreements, non-disclosure agreements, contract execution, vendor purchase orders, & miscellaneous study requests.
Reconciliation & management of key documents (plans, contact lists, etc.).
Assist in any purchase order (PO) related inquiries.
Assist in any subject travel inquiries, escalations, or exceptions.
Ensure vendor PO contains funds for insurance & translation vendors.
Invoice management for insurance & translations.
Ensure ICF form sign offs are filed in TMF for all local ICFs.
Ensure appropriate versioning & tracking for countries & sites.
Provide administrative assistance with internal & external meetings.
Assist in the preparation of investigator meeting materials.
Assist with Investigational Product (IP) Pack Release form review quality control checks.
Manage various Clin Ops document translations.
Assisting in the management of CRO deliverables (from meeting minutes to finalized ICF).
Process documents for signature in DocuSign.
Ensure accurate study entry & updates to ClinicalTrials.gov
Ensure MVR tracking & filing of sponsor comments.
Identify issues, with potential resolution, & escalate to the Study Specialist/SOL.
Assist in the conduct of study close-out activities (sites, reconciliation activities, filing & archiving).
Track & collate clinical trial documentation related to CSR appendices.
Request & coordinate written approval for country insurance policies, site specific certificates, & their updates.
Ensure appropriate distribution & archiving of policies & certificates.
Track insurance expiry dates.
Initiate extensions of expiring policies & processing of certificates.
Assist in IP related task as requested by the Clin Ops team.
Assist in managing ancillary supplies including at vendor/sites.
Attend internal Clin Ops team meeting & sub team meeting(s) & take meeting minutes as required.
The Clinical Trial Assistant is expected to be in the process of developing foundational competence in critical areas required for long term success in Clinical Operations across Communication and Collaboration, Proactivity and Adaptability, Analysis, Problem solving and Decision Making.
The Clinical Trial Assistant is also in the process of developing foundational technical competence in Compliance and Quality and Drug Development and Study Design.
Responds promptly with clear, organized written and oral communication.
Takes ownership and accountability for completing assigned tasks and perseveres through obstacles. Embraces new challenges or changed priorities and adjusts plans and priorities accordingly.
BA/BS or higher in nursing, life or health sciences is preferred.
Industry or relevant experience in lieu of education is considered.
1 year pharmaceutical industry experience.