Senior Initiation Clinical Research Associate

Parexel; Bengaluru; Hybrid; INR 1,600,000 - 2,100,000; Full time

Job summary

Parexel in Bengaluru is seeking an Initiation Clinical Research Associate (iCRA) specializing in Pre-SIV and Activation to lead study startup activities and serve as the primary site contact. You will manage regulatory submissions, site qualification, TMF quality, and activation readiness in a fast-paced, collaborative, matrix environment with flexibility for hybrid work.

This role offers opportunities to deepen expertise across regulatory, compliance, and study execution while delivering

Qualifications

• Degree-level education in biological science, pharmacy, or health-related discipline; nursing qualification acceptable.
• Startup experience in clinical research with understanding of trial methodology.
• Knowledge of ICH-GCP guidelines and regulatory requirements.
• Experience with CTMS and eTMF.
• Strong communication, organization and multitasking abilities.

Responsibilities

• Act as Parexel's primary contact with assigned sites during startup and activation.
• Support country-specific feasibility and site qualification activities (CDAs & QVs).
• Manage TMF issues and ensure FTQ documentation.
• Prepare and submit IRB/IEC and MoH/RA applications; follow up to approvals.
• Update CTMS with startup and amendment information; ensure activation readiness.

Skills

Problem solving

Independent work

Prioritization

Collaboration

Education

Life science degree

Tools

CTMS

eTMF

MS Office

Job description

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.

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 (iCRA) specializing in Pre-SIV and Activation tasks to join our team in India-Bengaluru capacity on a hybrid / on-site basis. As an iCRA, you will drive the strategy and execution of study startup, Pre-SIV, and activation activities while serving as Parexel's primary point of contact with assigned clinical sites. This position plays a critical role in ensuring regulatory compliance, maintaining trial master file quality, and supporting site readiness for successful study initiation.

You’ll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic site management, regulatory excellence, and collaborative problem-solving. With diverse teams and continuous learning opportunities, the iCRA role offers pathways to deepen expertise in clinical trial operations and expand skills across regulatory, compliance, and study execution functions.

Key Responsibilities

• Act as Parexel's direct point of contact with assigned sites, accountable for quality and delivery during the startup phase, including building relationships with investigators and site staff.
• Support country-specific feasibility and site qualification activities, including preparation, negotiation, and facilitation of Confidentiality Agreements (CDAs) and Qualification Visits (QVs).
• Manage country and site-level Trial Master File (TMF) issues, ensuring First Time Quality (FTQ) documentation and providing direct resolution to reported site problems.
• Develop and execute strategy for configuring, distributing, collecting, and reviewing high-quality country-specific and site-specific regulatory documents, including Site SIV Readiness documentation.
• Customize, review, and negotiate country/site-specific Informed Consent Forms (ICFs), translations, and amendments within regulatory parameters.
• Prepare and submit IRB/IEC and MoH/RA applications, resolving conflicts and determining appropriate follow-up until receipt of final approval.
• Update and maintain the Clinical Trial Management System (CTMS) in a timely manner with accurate startup and amendment information.
• Promptly identify, address, and resolve site questions and issues, including potential risks to activation timelines, recruitment strategy challenges, training deficiencies, and compliance concerns.
• Facilitate site access to relevant study systems and ensure compliance with all project-specific training requirements prior to study initiation.
• Actively participate in internal and external meetings as needed and maintain audit and inspection readiness at assigned sites.
• Work independently with limited oversight, proactively communicating progress, risks, and issues to management.

You'll Thrive In This Role If You Bring

• Strong problem-solving skills and the ability to work independently while proactively seeking guidance when necessary.
• Flexibility and willingness to learn, with the ability to prioritize multiple tasks and make autonomous decisions in a fast-paced environment.
• Comfort working in a matrix environment with strong collaboration and teamwork skills.
• A patient-focused mindset with strong attention to detail and commitment to high-quality, compliant work.
• Strong computer skills, including proficiency with Clinical Trial Management Systems (CTMS), Electronic Trial Master Files (eTMF), and Microsoft Office products.

Required Qualifications

• Degree-level education in biological science, pharmacy, or other health-related discipline, or equivalent nursing qualification or equivalent experience.
• Substantial startup experience or equivalent experience in clinical research, with demonstrated understanding of clinical trial methodology and terminology.
• Knowledge of ICH-GCP guidelines, regulatory requirements, and clinical trial processes.
• Experience with Clinical Trial Management Systems (CTMS) and Electronic Trial Master Files (eTMF).
• Strong communication, organization, and problem-solving skills with the ability to manage multiple priorities.

Preferred Qualifications

• Experience in regulatory affairs or site management functions.
• Familiarity with international regulatory requirements and multi-country study operations.
• Experience with study initiation or site activation processes.

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.