Study Start-Up Associate - Contractor (United States)

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 Study Start-Up Associate - 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 Study Start-Up Associate (Contractor) 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.

In this role your key tasks will include:

General activities

• Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities (as defined below)
• 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

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 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

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 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 negotiate clinical trial agreements and budgets: 
• Contribute to other areas of business as required

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 Study Start-Up Assoc...

To be successful you will possess:

• 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