iCRAII
Primary Location: India, Remote Job ID R0000036088 Category Clinical Trials Date Posted 11/14/2025Overview
As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity.
Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas. We’re looking for people who want to grow personally and professionally and support their colleagues globally and cross-functionally.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Flexible
- Organized
- Problem-solver
- Self-starter
About This Role
Responsible for planning and delivery of European Union Clinical Trials Directive/Regulation (EUCTD/R) reporting according to the Part II requirements outlined by the European Medicines Agency (EMA) via the Clinical Trial Information System (CTIS). Coordination with Regulatory Affairs, Clinical Trial Management and Clinical Transparency will be core to the role.
Key Accountabilities:
Operations Management:
Engage with Regulatory Affairs functional representatives to plan the Clinical Trial Application (CTA) for any one up and coming clinical trial that involves EU countries
Engage with Clinical Trial Management functional representatives to determine key study milestones and country allocation strategies
Coordinate with Clinical Transparency regarding any redactions required for relevant documents identified for CTA submissions
Identify the list of Member State/countries participating in any one clinical trial and capture the information within the CTIS database
Identify the key study level and Member State/country level milestones that represent Study Start, Study Completion, Enrollment Start, Enrollment Completion and any potential hold/restart/cancel dates that may apply to the study and capture the relevant dates within the CTIS database
Identify the Institutions and Primary Investigators for each Member State/Country where the clinical trial will be conducted and capture relevant contact information within the CTIS database
Locate the documents that are deemed applicable at the Member State/country and/or site level for the purposes of Clinical Trial Application (CTA) submissions and upload them into the CTIS database
Maintain the list of participating Member States/countries, Institutions and Primary Investigator over the life cycle of the study to ensure alignment and synchronization.
Triage any questions that surface (RFIs, Requests For Information) as a result of capturing and/or reporting on REGN clinical trial applications
Engage and oversee any vendor engaged to help collect, enter and/or maintain relevant information regarding Clinical Trial Applications (CTA) via the EMA CTIS database
Document Management:
Under supervision perform basic document management tasks including file transfer, storage, tracking, and archival of Regulatory Guidelines
Develop a familiarity with current global regulatory submission standards.
Compliance with Parexel Standards:
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains effective relationships with other platform lines, Business Units/Research Units, and enabling lines that facilitate effective portfolio delivery
Skills:
Working knowledge of the clinical drug development process, ICH/GCP and regulatory guidelines/directives
Strong familiarity with EUCTD/R and Federal Code of Regulations
Familiarity with Veeva Vault Clinical for CTMS and eTMF use
Demonstrates ability to prioritize and manage multiple projects simultaneously
Demonstrates effective problem solving and decision-making skills
Interpersonal, collaboration and stakeholder management skills
Good communication (written/verbal)
Highly organized, detail oriented
Ability to synthesize information and demonstrate strategic thinking
Self-motivated, flexible, able to follow through in a fast-paced environment, ability to meet deadlines under pressure
Computer skills with competency in MS suite a plus
May require up to 25% travel
Knowledge and Experience:
Minimum 1-3 years of relevant/clinical essential document review experience
Education:
Bachelor’s degree
#LI-REMOTE
Potential Career Path
Parexel offers various career paths and internal development programs for CRAs to advance to the next level. This could include enhancing your technical position, moving into management, or shifting to other areas of the business.
- APEX CRA
- CRA I
- CRA II
- Senior CRA
- Project ManagementSubject Matter ExpertPeople Management
Employee Insights
TEAM IMPRESSIONS
Why Clinical Research Associates work at Parexel
