Start-Up Associate/Sr. Start-Up Associate - Contractor (USA)

About the role

At Allucent™, we help small-medium biopharmaceutical companies efficiently manage clinical trials to bring life-changing therapies to patients globally. We are seeking a Start-Up Associate/Sr. Start-up Associate (Contractor) to join our team.

Responsibilities

• Coordinate and support local site start-up activities, including essential record collection, IEC/IRB submission/approval activities, and country/site ICF review.
• Support communication to RA, IEC/IRB, and investigators/sites through the initial phase of a clinical study until the Site Initiation Visit.
• Track relevant information, data, progress, and milestones in CTMS and/or other tracking tools.
• File documents in the (e)TMF for which they are the document owner.
• Avoid duplicate tasks by assisting other Study Start-up team members with filing documents in the (e)TMF.
• Complete handover of site to CRA at time of IEC/IRB submission/approval activities.
• Support sponsor and sites in preparing, compiling, submitting, and maintaining ethical requirements and documentation required by IEC/IRB for clinical trials at local level.
• Provide and review relevant documents in compliance with ethical requirements and per local legislation.
• Support interactions with IEC/IRB by assisting in the preparation and compilation of answers for questions raised by the IEC/IRB and submitting the answers.
• Complete adaptation of Master ICF to country and/or site-specific requirements.
• Assist in the preparation and compilation of Essential Records Package and send package to sites.
• Complete collection and first review of Essential Records.
• Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution.
• Support feasibility and/or site identification activities.
• Negotiate clinical agreements and budgets.
• Contribute to other areas of business as required.

Requirements

• Bachelor’s degree in life sciences, healthcare, or a related biological discipline, or an equivalent combination of education, training, and relevant experience.
• Minimum of 3 years of experience in drug development and/or clinical research. For senior-level roles, a minimum of 5 years of experience is required.
• Minimum 2 years of experience in a similar role, or an equivalent combination of education, training, and experience in the CRO/Pharma industry. For senior-level roles, a minimum of 4 years of experience is required.
• 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.

Benefits

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."