Reg & Start Up Spec 1

Job Overview:
Responsible for collaborating with the strategic CSS in the creation and distribution of various documents and system builds to drive effective and efficient study start-up activities globally.

Responsibilities:
Responsibilities include but are not limited to:

Survey build (Key study document list): Creation of electronic survey build based off required documents needed for study.
Package build: Prepare and build electronic packages within our system for sites which may include essential documents, regulatory documents, etc.
Query Tracking process: Track queries issued by regulatory bodies within our electronic system.
Informed Consent Form (ICF) build: Create ICF template based on country requirements as received from affiliate.
Essential Document Review: Review essential documents against checklist per country regulations.
Completion of any other defined transactional activities, i.e., Clinical Study Report (CSR), Trial Master File Oversight.

Qualifications:
Bachelors Degree (degree in health care or scientific field) highly preferred or equivalent years of experience required
Competent use of Excel.
Minimum of 1-2 years of clinical research experience and a minimum of 1+ years of study start up experience.
Experience with ICF review
Experience reviewing essential documents
Experience working with IRB/IEC and competent authority submissions and approvals
Prior experience working with Vault Clinical (or similar tracking system)