Study Start-Up Associate - Contractor (United States)

About the role

As a Study Start-Up Associate (Contractor) at Allucent, you will coordinate and support local site start-up activities, including essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission and approval activities. You will support communication to RA/IEC/IRB, investigators, and sites through the initial phase of a clinical study until the Site Initiation Visit.

Responsibilities

• General activities
  • Track relevant information, data, progress, and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities.
  • Ensure planned dates are reliable and up-to-date in CTMS.
  • File documents in the (e)TMF for which you are the document owner.
  • Assist other Study Start-up team members with filing documents in the (e)TMF for which they are the document owner.
• RA submission/approval activities (if applicable)
  • Assist in the preparation, compilation, submission, and maintenance of regulatory documentation required by regulatory agencies for clinical trials at the local level.
  • Support providing relevant documents in compliance with local regulations.
  • Support review of technical, pre-clinical, and clinical reports for regulatory submissions.
  • Assist in interactions with regulatory authorities.
  • Assist in the preparation and compilation of answers for questions raised by regulatory agencies and submit the answers.
  • Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate.
  • Support Global Regulatory Manager (GRM) and/or Global Submission Specialist (GSS) as needed.
• IEC/IRB submission/approval activities
  • Assist in the preparation, compilation, submission, and maintenance of ethical requirements and documentation required by IEC/IRB for clinical trials and marketing applications at the local level.
  • Assist in providing and reviewing relevant documents in compliance with ethical requirements and per local legislation.
  • Assist in interactions with IEC/IRB.
  • Assist in the preparation and compilation of answers for questions raised by the IEC/IRB and submit the answers.
  • Regularly check for updates on regulations, guidelines, and procedures. Ensure these changes and updates are communicated and circulated as appropriate.
  • Assist in adapting country SIS/ISF to country and/or site-specific requirements.
• Essential Document collection activities
  • Assist in the preparation of the site-specific Essential Document Package and sending to sites.
  • Support collection and first review of Essential Documents.
  • Provide the Global Essential Document Reviewer with the collected documents for independent review.
  • Assist in following up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution.
  • Assist in obtaining authorization for the shipment of Investigational Product to the site.
• Other activities
  • May support feasibility and/or site identification activities.
  • May contribute to negotiating clinical trial agreements and budgets.
  • Contribute to other areas of business as required.

Requirements

• Life Science, Healthcare, or Biological Science degree; or equivalent combination of education, training, and experience.
• Minimum 2 years of relevant clinical development experience.
• Fundamental knowledge of GxP, privacy legislation (GDPR and/or HIPAA), and applicable local regulatory requirements preferred.
• Fundamental knowledge of the country or region competent authority submission process, reporting requirements, and guidelines.
• Strong written and verbal communication skills, including a good command of the English language.
• Ability to work in a fast-paced, challenging environment of a growing company.
• Representative, outgoing, and client-focused.
• Strong organization and time management skills.
• Strong attention to detail and accuracy.
• Proficiency with various computer applications such as Word, Excel, and PowerPoint.