When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
About Parexel
Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22000 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 Parexels 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.
Youll 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 Parexels 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.
Youll 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 solid 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.
If this job doesnt sound like the next step in your career but perhaps you know of someone whod be a perfect fit send them the link to apply!