Study Start-Up Associate - Contractor (United States) in Cary, North Carolina at Allucent

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

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

Disclaimers:

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

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