Clinical Start-Up Specialist

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

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,