Confidential
Job Title: Start-Up Associate/Sr. Start-Up Associate – Contractor (USA)
Company: Confidential
Location: United States (Remote)
Work Type: remote
Description
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.
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 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
IEC/IRB submission/approval activities
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
Essential Document collection activities
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
Other activities:
May support feasibility and/or site identification activities
May negotiate clinical agreements and budgets
Contribute to other areas of business as required
Requirements
To be successful you will possess:
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
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.”
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