Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required. Assists with EC/IRB or CA issue resolution at the country level.
Performs essential document collection and review, ensuring that sponsor and investigator requirements are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
Conducts the site identification process by contacting sites to confirm the investigator's interest and eligibility to participate in a clinical trial protocol. Liaises with the Site Identification Lead to assist Medical Informatics team with site outreach for pre-award assessments as needed.
Prepares Investigational Product (IP) checklist according to country regulations.
Ensures accuracy and completeness of Trial Master File documents submitted throughout the study and performs a QC review of files for which Start-up Associate is acting as document owner, in line with the requirements set in the File Management Plan.
Provides all regulatory documents and relevant study correspondence along with translations to the Clinical Research Associate throughout the study conduct.
Collects information on submission deadlines and timeline metrics for RAs, ECs, IRBs and other local bodies as appropriate.
Liaises with internal team members to review areas that impact study start-up and shares start-up information with the project team.
Provides guidance on data protection compliance at a country level for data protection statements that need to be included on documents which the Sponsor has contracted to the Company start-up group; this typically includes the Principal Investigator/Informed Consent and the CDA/contract template.
Sets up and maintains a folder with country ECs/IRBs and local authority addresses and requirements, as required.
The SSUA may set up and maintain details of existing site and institution contract requirements, as well as the necessary templates and fees, on the Global Study Start-Up portal on SharePoint.
Provides quality review of the informed consent and adapts the template as appropriate, as well as other patient documents, or specific documentation that is required in the country.
Works within the scope of Regulatory Start Up plan (RSSP), study processes, applicable regulations, ICH-GCP and/or ISO14155 and any other requirements mandated by the study.
May provide regular updates of country specific information on the Global Study Start-Up portal on SharePoint.
Enters and maintains trial status information relating to SSU activities into Premier's tracking databases, in an accurate and timely manner.
Ensures documentation of QC of eTMF within the scope of File Management Plan (FMP) from the Study Start-Up phase or other sections where the Start-up Associate is acting as document owner as the final deliverable to the client.
May support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.
Provides training for local employees and other applica
Additional Information
Premier Research is looking for a Sr/Site Start Up Associate II to join our Global SSU team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
Premierresearch · Australia