Study Start Up Associate II (Remote)

Job summary

As a Study Start Up Associate II, you will lead the initiation of clinical trials, ensuring compliance with regulatory standards while contributing to the advancement of new treatments. This role involves collaborating with various teams to enhance site start-up and activation processes.

Qualifications

• Bachelor's degree or international equivalent
• Minimum of 2 years of experience in clinical research Site Start Up within a pharmaceutical company, CRO, or relevant industry vendor
• Ability to interpret data for informed decision-making
• Knowledge of clinical study protocols and essential documents
• Strong organizational, decision-making, communication, and negotiation skills
• Proficient in Microsoft Excel, Word, and PowerPoint

Responsibilities

Rewards & Benefits

• Collaborate with assigned sites for essential document collection and review
• Partner with internal teams and external partners to improve site start-up metrics
• Ensure compliance with standards across projects
• Review essential documents for site start-up, including ICF, FDF, 1572, CVs, etc.
• Identify and address potential site activation delays
• Track actions and communications with sites to meet study timelines
• Assist in resolving escalated issues with CROs and Clinical Operations teams
• Provide feedback on site performance metrics to management
• Ensure the accuracy and completeness of the eTMF for assigned sites during start-up
• Competitive salary and performance-related incentives
• Health and wellbeing programs, including medical, dental, and vision coverage
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programs and wellbeing resources
• Learning and development opportunities