Clinical Research Associate II Job at Parexel (Bengaluru)

Clinical Research Associate II

Parexel

Location:
India , Bengaluru

Category:
Research and Development

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

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.

Job Responsibility:

Act as Parexel’s direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase
Build relationships with investigators and site staff
Support on request country specific feasibility and/or site pre-qualification and qualification activities
Manage country and site level TMF issues ensuring documents’ First Time Quality (FTQ) as well as providing direct resolution to reported site problems
Develop strategy to configure, distribute, collect, and review and approve, high quality country specific and/or site specific documents or essential regulatory documents
Customize, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations, and customize and negotiate any amendments
Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval
Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy
Forecast, develop, manage, and revise plans and strategies for IRB/IEC and MoH / RA submission/approval and Site activation
Update and maintain appropriate Clinical Trial Management System (CTMS) in a timely manner
Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue
Facilitate and support allocated sites with access to relevant study systems and ensure they are compliant with all project specific training requirements prior to study start
Actively participate in internal and/or external meetings as per project needs, Sponsor’s expectations and at Manager discretion
Work in a self-driven capacity, with limited need for oversight
Proactively keep manager informed about work progress and any risk or issues
Ensure timely and accurate completion of project goals and update of applicable trial management systems with start -up and amendments
Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required
Ensure that assigned sites are audit and inspection ready
Monitor and maintain compliance with ICH-GCP and applicable international and local regulations
Show commitment and perform consistent high quality work
Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training
Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery
Provide input and feedback for Performance Development Conversation(s)
Develop expertise to become a subject matter expert
Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)

Requirements:

Substantial start up experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
Demonstrate strong problem-solving skills
Able to take initiative and work independently, and to proactively seek guidance when necessary
Excellent presentation skills
Client focused approach to work
Ability to interact professionally within a client organization
Flexible attitude with respect to work assignments and new learning
Ability to prioritize multiple tasks and achieve project timelines
utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise
Strong ability to make appropriate decisions in ambiguous situations
Willingness to work in a matrix environment and to value the importance of teamwork
Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Trial Master File (eTMF), and MS-Office products such as Excel and Word
Excellent interpersonal, verbal, and written communication skills
Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables
Excellent time management in order to meet study needs, team objectives, and department goals
Proven ability to work across cultures
Shows commitment to and performs consistently high-quality work
Ability to successfully work in a (‘virtual’) team environment
Act as a mentor and role model for other team members
Effectively enlist the support of team members in meeting goals
Attention to detail

Nice to have:

Communicator
Detail-oriented
Flexible
Organized
Problem-solver
Self-starter

What we offer:

Patient-focused in everything we do
Supportive and inclusive environment
Career growth and development
Flexible work arrangements
Diverse therapeutic areas and project exposure
Advanced Technology

Additional Information:

Job Posted:
January 18, 2026

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