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Parexel
Parexel Initiation Clinical Research Associate I Recruitment 2026: Apply Online for Various Vacancies
Initiation Clinical Research Associate I
Experience Required
Substantial start up experience or equivalent experience in clinical research
Salary / Package
Competitive
Work Mode
Flexible (In-office, Home-based, or Hybrid)
Openings
Multiple
Job Overview
As an Initiation Clinical Research Associate I (iCRA I) at Parexel, you will play a pivotal role in accelerating the delivery of life-saving treatments to patients worldwide. This position is specifically tailored for professionals specializing in Pre-Site Initiation Visit (Pre-SIV) and Activation tasks. You will be directly accountable for managing and driving the strategic execution of study start-up activities, ensuring that clinical sites are fully prepared, compliant, and authorized to begin trials.
- Study Start-Up Management: You will act as Parexel’s primary point of contact for assigned clinical sites, taking full ownership of quality and delivery timelines during the critical start-up phase. This includes building strong, collaborative relationships with principal investigators and site staff to facilitate smooth operations.
- Feasibility and Qualification: You will support country-specific feasibility assessments and site pre-qualification activities. This involves preparing, negotiating, and executing Confidentiality Agreements (CDAs) and conducting remote Qualification Visits (QVs) to assess site suitability.
- Regulatory Submissions: You will customize, review, and negotiate country- and site-specific Informed Consent Forms (ICFs) and their translations. You will also prepare and submit applications to Institutional Review Boards (IRBs), Independent Ethics Committees (IECs), and Ministries of Health (MoH) or Regulatory Authorities, resolving any queries until final approval is secured.
- Trial Master File (TMF) Maintenance: Ensuring First Time Quality (FTQ) is a core expectation. You will manage country- and site-level TMF issues, resolve document discrepancies, and submit all pertinent documentation to the TMF in accordance with project plans and sponsor policies.
- Systems and Compliance: You will update and maintain the Clinical Trial Management System (CTMS) on an ongoing basis. You will also ensure that assigned sites are fully trained, compliant with ICH-GCP guidelines, and have proper access to study systems prior to study initiation.
Key Job Details
| Company Name | Parexel |
| Job Role | Initiation Clinical Research Associate I |
| Experience | Substantial start up experience or equivalent experience in clinical research |
| Salary Range | Competitive |
| Job Type | Full Time |
| Work Mode | Flexible (In-office, Home-based, or Hybrid) |
| Openings | Multiple |
| Job Location | Bengaluru, India |
Key Responsibilities
- Act as Parexel’s direct point of contact with assigned clinical sites during the start-up phase.
- Build and maintain strong relationships with investigators and site staff.
- Support country-specific feasibility and site pre-qualification/qualification activities.
- Prepare, negotiate, and facilitate execution of Confidentiality Agreements (CDA) and amendments.
- Manage country and site-level Trial Master File (TMF) issues ensuring First Time Quality (FTQ).
- Customize, review, and negotiate country/site-specific Informed Consent Forms (ICF).
- Prepare and submit IRB/IEC and Ministry of Health/Regulatory Authority applications.
- Update and maintain the Clinical Trial Management System (CTMS) in a timely manner.
Requirements & Qualifications
- Substantial start-up experience or equivalent experience in clinical research.
- Deep understanding of clinical trials methodology and terminology.
- Educated to degree level in biological science, pharmacy, or other health-related discipline.
- Equivalent nursing qualification or other equivalent experience is also acceptable.
- Willingness to work in a matrix and virtual team environment.
- Commitment to performing consistent high-quality work.
Required Skills
- Strong problem-solving and analytical skills.
- Ability to take initiative and work independently.
- Excellent presentation and interpersonal skills.
- Client-focused approach to work.
- Flexible attitude with respect to work assignments.
- Strong computer skills (CTMS, eTMF, MS Office).
- Excellent verbal and written communication skills.
- Attention to detail and time management.
About Parexel
Parexel is a leading global clinical research organization (CRO) that provides a comprehensive range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. With a collaborative, inclusive, and patient-first culture, Parexel operates globally to support biopharmaceutical and medical device industries.
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Frequently Asked Questions
Q: What is the role of an Initiation Clinical Research Associate I (iCRA I) at Parexel?
A: The iCRA I specializes in Pre-SIV (Site Initiation Visit) and Activation tasks, managing and driving the strategy for study start-up, regulatory submissions, and site activation.
Q: What are the educational requirements for this position?
A: Candidates should be educated to degree level in biological science, pharmacy, or another health-related discipline. Equivalent nursing qualifications or clinical research experience are also accepted.
Q: Where is the job location for this recruitment?
A: The position is based in Bengaluru, Karnataka, India, with flexible work options available.
Q: What skills are essential for the iCRA I role?
A: Key skills include strong problem-solving, excellent communication, familiarity with CTMS and eTMF systems, knowledge of ICH-GCP guidelines, and attention to detail.
Q: Does Parexel offer flexible work arrangements?
A: Yes, Parexel offers a Flexible Work Program focusing on outputs and results, allowing for in-office, home-based, or hybrid work setups.
Q: How can I apply for the Parexel iCRA I position?
A: You can apply online by visiting the direct Parexel Workday application link, filling out your details, and uploading your updated resume.
Disclaimer: This job post is prepared by collecting data from the official career page of Parexel. We are not direct recruiters or representatives. Candidates should carefully review the requirements and policies on the company’s portal before initiating an application.