Parexel Hiring Clinical Research Associate | Clinical Research Job Opportunity | Apply Now
Looking for a Pharma Job in the clinical domain? This exciting Clinical Research Job opportunity at Parexel for the role of Initiation Clinical Research Associate I is perfect for candidates aiming to build a strong career in clinical trials, regulatory processes, and patient safety. If you are searching for a Pharma Job with global exposure, this Clinical Research Job offers the right platform to grow professionally.
- Job Title: Initiation Clinical Research Associate I
- Location: India, Bengaluru
About the Company
Parexel is a leading global clinical research organization (CRO) that helps bring life-saving treatments to patients faster. This Pharma Job and Clinical Research Job opportunity allows candidates to work in a high-impact environment focused on innovation, quality, and patient safety across multiple therapeutic areas.
Job Description
- Work as a Clinical Research Associate (CRA) to help bring treatments to patients faster
- Ensure patient safety and well-being is always the top priority
- Visit investigator sites and perform monitoring activities
- Be inquisitive, accountable, and build strong relationships with site teams
- Work with a diverse global team across multiple therapeutic areas
- Get opportunities for personal and professional growth
- Support colleagues across global and cross-functional teams
iCRA (Initiation CRA) Responsibilities
- Manage and drive study start-up activities (Pre-SIV & Activation tasks)
- Take responsibility for planning and executing start-up strategies
- Support submission and approval of protocol amendments if required
Key Responsibilities
Start-up Phase
- Act as Parexel’s direct point of contact with assigned sites
- Build relationships with investigators and site staff
- Support feasibility, pre-qualification, and qualification activities
- Preparation and negotiation of Confidentiality Agreements (CDA)
- Conduct remote Qualification Visits (QVs)
- Manage Clinical Site Agreements (CSA) timelines
- Ensure First Time Quality (FTQ) documentation in TMF
- Review and approve regulatory and essential documents
- Customize and negotiate Informed Consent Forms (ICF)
- Prepare and submit IRB/IEC and MoH/RA applications
- Maintain Clinical Trial Management System (CTMS) updates
- Identify and resolve site issues and risks
- Ensure training compliance before study start
Maintenance Phase
- Manage ICF updates and amendments
- Submit regulatory applications and follow-ups
- Maintain trial master file documentation
- Forecast and manage regulatory submission timelines
Overall Responsibilities
- Ensure timely completion of project goals
- Maintain CTMS and Trial Master File (TMF)
- Ensure audit and inspection readiness
- Maintain compliance with ICH-GCP and regulations
- Collaborate with cross-functional teams
- Deliver high-quality work consistently
- Maintain communication with stakeholders and managers
Qualifications
- Degree in biological science, pharmacy, or other health-related discipline preferred
- Equivalent nursing qualification or relevant experience
Skills
- Strong problem-solving skills
- Ability to work independently and take initiative
- Excellent communication and presentation skills
- Strong analytical and decision-making abilities
- Knowledge of CTMS, eTMF, MS Excel, and Word
- Time management and multitasking skills
- Ability to work in cross-cultural and virtual teams
- Attention to detail and quality focus
Knowledge and Experience
- Substantial start-up experience or equivalent experience in clinical research
- Understanding of clinical trials methodology and terminology
