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

Allucent; Cary (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

Allucent in the United States is seeking a Start-Up Associate (Contractor) to support local site start-up activities across Study Start-up & Site Intelligence. You will coordinate essential records, IEC/IRB submission/approval activities, and country/site ICF review to enable timely Site Initiation.

In this role you will track milestones in CTMS, file documents in the eTMF, assist investigators and sites, and support communications with RA/IEC/IRB throughout early study phases.

Qualifications

• Bachelor's degree in life sciences or related field; 3+ years in drug development/clinical research; senior level 5+ years.
• 2+ years in CRO/Pharma; senior level 4+ years; industry experience preferred.
• Fundamental knowledge of GxP, privacy legislation (GDPR/HIPAA), local regulations.
• Strong written and verbal communication in English.
• Ability to work in a fast-paced, client-focused environment; highly organized.

Responsibilities

• Track progress and milestones in CTMS for Start-Up activities.
• Ensure site start-up milestone dates are reliable and up to date in CTMS.
• File documents in the (e)TMF as document owner.
• Assist team with filing documents in the (e)TMF for which they are owner.
• Complete handover of site to CRA at time of SIV.
• Assist with IEC/IRB submission, responses, and approvals.
• Prepare and adapt Master ICF to country/site needs.
• Prepare site-specific Essential Records Package.

Skills

Project coordination

GxP knowledge

English communication

CTMS proficiency

Documentation management

Education

Bachelor's degree in life sciences or related field

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Allucent

Location: United States

Department: Global Clinical Operations (GCO)

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

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