Local Start Up Specialist - Contractor (United States)

Allucent

1d • Remote

About The Position

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Local Start Up Specialist Contractor to join our A-team. As a at Allucent, you will coordinate and support local site start-up activities of Allucent Study Start-up & Site Intelligence. This may include essential document collection, Regulatory Authority (RA) and Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities. The LSUS I supports communication to RA/ IEC/ IRB as well as investigators and sites through the initial phase of a clinical study until the Site Initiation Visit.

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 HIPPA), 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 good command of 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 required.

Responsibilities

• 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 they are the document owner.
• Assist other Study Start-up team members with filing documents in the (e)TMF for which they are document owner.
• Assist in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials at local level.
• Support providing relevant documents in compliance with local regulation.
• 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 the 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.
• Assist in the preparation, compilation, submission and maintenance of ethical requirements and documentation required by IEC/IRB for clinical trials and marketing applications at 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.
• 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.
• May support feasibility and/or site identification activities.
• Contribute to other areas of business as required.

What This Job Offers

• Career Level: Entry Level