Study Start-Up Associate – Contractor

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

📋 Description

• Monitor pertinent information, data, progress, and milestones in CTMS and/or other tracking tools for designated start-up activities.

• Ensure that planned site start-up milestone dates are precise and current in CTMS.

• Organize documents in the (e)TMF for which you are the document owner.

• Support other Study Start-Up team members with document filing in the (e)TMF.

• Complete the site handover to the CRA during the SIV.

• Assist the sponsor and sites with preparing, compiling, submitting, and maintaining the necessary ethics requirements and documentation mandated by the IEC/IRB.

• Provide and review relevant documents to ensure compliance with ethical standards and local laws.

• Facilitate interactions with the IEC/IRB.

• Prepare, compile, and submit responses to queries from the IEC/IRB.

• Modify the Master ICF to meet country- and site-specific requirements.

• Create site-specific Essential Records Packages and distribute them to the sites.

• Gather and perform an initial review of Essential Records.

• Supply collected documents to the Global Essential Document Reviewer for independent assessment.

• Follow up with sites on document inconsistencies until resolved.

• May assist with feasibility and/or site identification tasks.

• May negotiate clinical trial agreements and budgets.

• Contribute to other business areas as necessary.

⛳️ Requirements

• Bachelor's degree in life sciences, healthcare, or a related biological field, or a comparable mix of education, training, and relevant experience.

• At least 3 years of experience in drug development and/or clinical research.

• A minimum of 2 years of experience in a similar position, or an equivalent mix of education, training, and experience within the CRO/pharmaceutical sector.

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

• Fundamental knowledge of the competent authority submission process, reporting obligations, and guidelines pertinent to the country or region.

• Excellent written and verbal communication skills, including a strong command of English.

• Capability to operate in a fast-paced, demanding environment within a growing organization.

• Professional, approachable, and client-oriented.

• Strong organizational and time-management abilities.

• High attention to detail and accuracy.

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

🏝️ Benefits

• Comprehensive health insurance plans.

• Opportunities for professional development and training.

• Flexible work arrangements.

• A collaborative and dynamic work environment.