Global Start-Up Associate – Clinical Trials

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 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.