Initiation Clinical Research Associate II

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

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