Clinical Research Associate Job at Parexel | Pharmacy Graduates Apply Now
Parexel is hiring an iCRA II for its Bengaluru operations. Specializing in Pre-SIV (Site Initiation Visit) and Activation tasks, this Clinical Research Associate Job is accountable for driving the strategy for clinical site start-up, managing IRB/IEC submissions, and ensuring Trial Master File (TMF) quality. Ideal for candidates with a biological science or pharmacy degree and substantial experience in clinical research start-up, the position offers the chance to work in a high-performance, matrix environment focused on improving global health.
- Job Title: iCRA II
- Location: India-Bengaluru
- Job Requisition ID: R0000036655
About The Company
Parexel is a global leader in clinical development, dedicated to improving the world’s health through a comprehensive suite of services that include clinical trials, regulatory consulting, and market access solutions. Driven by a deep conviction that every contributor plays a role in delivering life-saving therapies to patients, the company fosters an empathetic and high-performance culture.
Role Overview
An initiation Clinical Research Associate (iCRA) specializing in Pre-SIV and Activation tasks will be assigned & accountable for managing and driving the strategy for the startup, Pre-SIV, and Activation tasks of the study. The iCRA also supports the submission and approval process for the protocol amendments if applicable in this Parexel Job.
Key Accountabilities
Start-up (from site identification through site activation):
- 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, which may include:
- Preparation, negotiation, and facilitation of the execution of Confidentiality Agreements (CDA) and any amendments.
- May conduct remote Qualification Visits (QVs).
- Liaison with stakeholders to understand Clinical Site Agreements (CSA) timelines.
- Manage country and site-level TMF issues, ensuring documents’ First Time Quality (FTQ) as well as providing direct resolution to reported site problems.
- Develop a strategy to configure, distribute, collect, review, and approve high-quality country-specific and/or site-specific documents or essential regulatory documents (Site SIV Readiness/Greenlight Documents) and any updated or amended regulatory documentation.
- Customize, review, and negotiate as needed, country/site-specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), 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.
Maintenance (from initiation through close out):
- Customize, review, and negotiate as needed, country/site-specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments as needed during maintenance.
- Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow-up until receipt of final approval.
Overall Accountabilities from Site Identification to Close out:
- 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 a strategy for efficient project planning and goal completion, and encourage the support of team members where required.
Education
Educated to degree level (pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
Knowledge and Experience
Substantial start-up experience or equivalent experience in clinical research, with an understanding of clinical trials methodology and terminology.
Skills
- Demonstrate strong problem-solving skills in this Parexel Job
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Client-focused approach to work.
- Ability to interact professionally within a client organization.
