Study Start-Up Associate – Contractor

🔥 0 minutes ago

🇺🇸 United States – Remote

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

👻 Ghost score 10%

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Allucent

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Allucent is a leading partner for small and mid-sized biotech companies, offering innovative regulatory and clinical development solutions. With over 30 years of experience, Allucent specializes in therapeutic expertise, clinical pharmacology, regulatory strategy, drug safety, and the pharmacovigilance processes needed to bring new therapies to market. Their comprehensive services address challenges from early-phase drug discovery through clinical trials and post-marketing surveillance, supporting various therapeutic areas such as oncology, infectious disease, neurology, autoimmune diseases, and rare diseases. Allucent's commitment to fostering breakthrough science helps biotech companies navigate the complexities of drug development efficiently and effectively.

📋 Description

• Coordinate and support local site start-up activities for clinical studies • Track information, data, progress, and milestones in CTMS and/or other tracking tools • Ensure planned dates are reliable and current in CTMS • File owned documents in the (e)TMF and assist team members with document filing • Assist with preparation, compilation, submission, and maintenance of regulatory documentation • Support provision and review of documents for local regulatory compliance • Assist with regulatory authority interactions and responses to agency questions • Monitor updates to regulations, guidelines, and procedures and communicate changes • Support Global Regulatory Managers and/or Global Submission Specialists as needed • Assist with IEC/IRB ethical submissions, approvals, interactions, and responses • Adapt country SIS/ISF to country- and/or site-specific requirements • Prepare site-specific Essential Document Packages and send them to sites • Support collection and first review of Essential Documents • Follow up on document discrepancies through resolution • Assist in obtaining authorization for shipment of Investigational Product to sites • May support feasibility and/or site identification activities • May negotiate clinical trial agreements and budgets • Contribute to other areas of the 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 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