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

Allucent; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Allucent is seeking a Start-Up Associate (Contractor) to coordinate local site start-up activities, IEC/IRB submissions, and ICf reviews for clinical trials. The role supports communication with RA/IEC/IRB, investigators, and sites through the early phase until Site Initiation Visit.

You will manage Essential Documents, CTMS updates, and eTMF filing with attention to timelines and accuracy. The ideal candidate has a life sciences background, 3+ years in drug development or clinical research,

Qualifications

• Bachelor’s degree in life sciences, healthcare, or related field.
• Minimum 3 years of experience in drug development and/or clinical research.
• Fundamental knowledge of GxP, privacy legislation (GDPR and/or HIPAA), and applicable local regulatory requirements.
• Strong written and verbal English communication.

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.
• Provide and review 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

Skills

Communication skills

Organization skills

Time management

English language

Attention to detail

Education

Bachelor’s degree in life sciences or related field

Tools

Word

Excel

PowerPoint

Job 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 roleyour 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

To be successful you will possess:

• Bachelor’s degree inlife sciences, healthcare, or a related biological discipline, or anequivalent combination of education, training, and relevant experience. Minimum of3 years of experience in drug development and/or clinical research. ForSenior-level roles, a minimum of5 years of experience in drug development and/or clinical researchis required.
• Minimum 2 years of experiencein a similar role, or an equivalent combination of education, training, and experience in theCRO/Pharma industry. Forsenior-level roles, a minimum of4 years of experienceis 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

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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