Study Start-Up Associate – Contractor

This is a fully remote position, open to applicants in United States.

📋 Description

• Coordinate and facilitate local site initiation activities for clinical trials

• Monitor information, data, progress, and milestones using CTMS and/or other tracking systems

• Ensure that planned dates in CTMS are accurate and up-to-date

• Organize and store owned documents in the (e)TMF and assist colleagues with document organization

• Aid in the preparation, compilation, submission, and upkeep of regulatory documents

• Assist in the provision and review of documents to ensure local regulatory compliance

• Support interactions with regulatory authorities and manage responses to agency inquiries

• Keep track of updates to regulations, guidelines, and procedures, and disseminate changes

• Provide support to Global Regulatory Managers and/or Global Submission Specialists as required

• Assist with submissions, approvals, interactions, and responses related to IEC/IRB ethics

• Modify country SIS/ISF to align with country- and/or site-specific requirements

• Prepare site-specific Essential Document Packages and distribute them to sites

• Support the collection and initial review of Essential Documents

• Follow up on document discrepancies until resolved

• Assist in securing authorization for the shipment of Investigational Product to sites

• May provide support for feasibility and/or site identification efforts

• May engage in negotiations regarding clinical trial agreements and budgets

• Contribute to other business areas as necessary

⛳️ Requirements

• Degree in Life Science, Healthcare, or Biological Science; or an equivalent combination of education, training, and experience

• At least 2 years of pertinent clinical development experience

• Basic understanding of GxP, privacy legislation (GDPR and/or HIPAA), and relevant local regulatory standards is preferred

• Foundational knowledge of the submission process for the country or region's competent authority, including reporting requirements and guidelines

• Excellent written and verbal communication skills, with a strong command of the English language

• Ability to thrive in a fast-paced, dynamic environment within a growing company

• Professional, outgoing, and client-oriented demeanor

• Strong organizational and time management capabilities

• Keen attention to detail and accuracy

• Proficiency in various computer applications such as Word, Excel, and PowerPoint is required

🏝️ Benefits

• Comprehensive health insurance coverage

• Opportunities for professional development and training

• Flexible working hours and remote work options

• Supportive and collaborative team environment

• Competitive salary and performance-based incentives