Study Start-up Associate – Site Activation Specialist

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

📋 Description

• Act as the primary liaison with investigative sites throughout site initiation and ongoing maintenance processes.

• Gather, organize, review for quality, format, compile, and monitor investigator and essential documentation.

• Ensure the submission of EC/IRB/Third party/Regulatory Authority and local applications within established timelines.

• Provide support and guidance to sites and authorities concerning submission criteria.

• Stay updated on regulatory legislation, guidelines, practices, and current standards.

• Function as the local authority for project initiation tasks in a designated country or region.

• Prepare country application forms, cover letters, and routine regulatory submissions, including INDs/CTAs.

• Coordinate with regulatory authorities, internal teams, external vendors, and investigative sites.

• Review final submission documents to ensure adherence to laws, guidelines, ICH/GCP, SOPs, and quality standards.

• Monitor start-up and maintenance activities, milestones, timelines, budgets, and deliverables.

• Identify, prevent, and escalate study issues and potential delivery risks.

• Tailor patient informed consent forms to meet local requirements and ensure protocol compliance.

• Assist in negotiating and tracking site contracts and budgets when necessary.

• Upload and oversee submission documentation, notifications, and alerts in CTIS for EU studies.

• Engage in team and project meetings.

• Mentor and train new hires and less experienced colleagues as appropriate.

⛳️ Requirements

• A university/college degree (preferred in life sciences) or certification in a related allied health profession from an accredited institution (e.g., nursing certification, medical or laboratory technology).

• A minimum of 2 years of experience in clinical research, clinical development, or the start-up/regulatory process.

• Strong understanding of ICH guidelines and RA, IRB/IEC regulations.

• Relevant and equivalent experience may be considered in place of educational qualifications.

• A High School Diploma or equivalent along with at least 2 years of work experience in clinical research may be taken into account.

• Proficient knowledge of applicable regulations and guidelines.

• Familiarity with investigator start-up documentation and contract/budget negotiation processes.

• Previous experience interacting with operational project teams and investigative sites.

• Comprehension of research protocol requirements.

• Ability to effectively communicate and educate others regarding research protocol requirements.

• Capability to work in a standard office environment.

🏝️ Benefits

• Flexible remote work options.

• Full-time employment opportunity.