Initiation Clinical Research Associate II

We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry leading innovation, With Heart.

About the Role

We are seeking an Initiation Clinical Research Associate II (Site Start Up EUCTR II) to join our team in a Hybrid capacity at our Hyderabad office. As an Initiation Clinical Research Associate II, you will support complex clinical trial initiation activities that advance new treatments for patients. This position plays a key role in regulatory strategy planning, study startup execution, and ensuring compliance with EU Clinical Trials Information System (CTIS) requirements. You'll collaborate with cross-functional teams including Clinical Trial Management, Regulatory Affairs, and Clinical Transparency to drive successful trial launches across multiple European Member States.

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic planning, regulatory coordination, and operational excellence. With diverse teams and continuous learning opportunities, the Clinical Research Associate II can explore career paths and expand skills across clinical research and regulatory operations.

Key Responsibilities

• Collaborate with Clinical Trial Management and Regulatory Affairs teams to develop comprehensive study startup strategies, including key study milestones and country allocation plans for multi-country clinical trials
• Plan and execute complex EU Clinical Trial Application (CTA) submissions for Part II trials, ensuring compliance with CTIS database requirements and national regulatory guidelines across all participating Member States
• Identify and manage participating Member States, institutions, and Primary Investigators, capturing and maintaining accurate contact information and institutional details within the CTIS database throughout the trial lifecycle
• Collect, organize, and upload applicable Member State and site-level documents for CTA submissions, coordinating with Clinical Transparency on required redactions and ensuring all documentation meets regulatory requirements
• Monitor and report on Part II CTA progress against trial timelines, identifying risks and ensuring alignment with overall study objectives and regulatory milestones
• Triage and coordinate responses to Requests for Information (RFI) from regulatory authorities, working with relevant stakeholders to ensure timely and compliant submissions
• Manage In Vitro Diagnostic Regulation (IVDR) ethics submissions, collecting required documents and verifying compliance with country-specific IVDR requirements
• Identify and capture key study-level and Member State-level milestones including Study Start, Study Completion, Enrollment Start, Enrollment Completion, and any hold/restart/cancel dates within the CTIS database
• Ensure all trial-related documents are properly archived in compliance with regulatory requirements and company policies

You'll thrive in this role if you bring:

• Strong interpersonal and leadership skills with the ability to influence cross-functional teams and build productive collaborations
• A data-driven approach to planning, executing, and problem-solving with proactive, self-disciplined work habits and excellent time management
• Effective verbal, written, and presentation communication skills with the ability to articulate complex regulatory concepts clearly
• Vendor management experience and comfort working with multiple stakeholders in a regulated environment
• A patient-focused mindset and strong attention to detail with commitment to regulatory compliance and data accuracy

Required Qualifications

• Bachelor's degree with 3-6 years of relevant experience in clinical research, study operations, or clinical trial management
• Knowledge of ICH-GCP, EUCTR, and IVDR regulatory guidelines and clinical trial processes
• Experience with trial management systems (CTMS) and electronic Trial Master Files (eTMF)
• Proficiency in MS Office applications including Project, PowerPoint, Word, and Excel
• Experience with CTIS database and EU regulatory submission processes
• Familiarity with clinical trial initiation and study startup procedures