Start-Up Associate/Sr. Start-Up Associate - Contractor (USA)
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 Start-Up Associate/Sr. Start-up Associate (Contractor) to join our A-team. As Allucent, you will coordinate and support local site start-up activities of Allucent Study Start-up & Site Intelligence. This may include essential record collection, Independent Ethics Committee (IEC)/Institutional Review Board (IRB) submission/approval activities, and country and site Informed Consent (ICF) review. The Start Up Associate (Contractor) will support 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
- 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 in drug development and/or clinical research 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.
Responsibilities
- Track relevant information, data, progress and milestones in CTMS and/or other tracking tools covering assigned Start-Up activities.
- Ensure site start-up milestone 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.
- Complete handover of site to CRA at time of SIV.
- Assist sponsor and sites in the preparation, compilation, submission and maintenance of ethical requirements and documentation required by IEC/IRB for clinical trials at local level.
- Providing and reviewing relevant documents in compliance with ethical requirements and per local legislation.
- Support in interactions with IEC/IRB.
- Assist in the preparation and compilation of answers for questions raised by the IEC/IRB and submit the answers.
- Complete adaptation of Master ICF to country and/ or site-specific requirements.
- Assist in the preparation of the site-specific Essential Records Package and send package to sites.
- Complete collection and first review of Essential Records.
- Provide the Global Essential Document Reviewer with the collected documents for independent review.
- Follow up with the sites regarding all document discrepancies noted by the Global Essential Document Reviewer until resolution.
- May support feasibility and/or site identification activities.
- May negotiate clinical agreements and budgets.
- Contribute to other areas of business as required.
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What This Job Offers
Career Level
Entry Level
