Initiation Clinical Research Associate II

Company Overview

Parexel can be described as one of the largest and most successful Clinical Research Organizations (CRO) in the world. CRO stands for any corporation which provides assistance to pharma and biotech organizations to successfully deliver new therapies for patients. This company was created back in 1982 and developed its operations throughout the whole world with thousands of workers who have offices around the globe. Its purpose consists of improvement of the health care system through assistance in therapy development.

In case a pharma company invents a new drug, it is not allowed to start selling it. A product needs to pass a special test in order to receive a permission from an appropriate institution. This process is called clinical trial and Parexel assists its customers in conducting this trial properly. The company deals with all processes connected with this procedure and cooperation with other institutions.

They involve clinical trials management, medical writing, data management, biostatistics, pharmacovigilance, and regulatory affairs. In providing the services offered, Parexel assists the pharmaceutical companies to collect and analyze information about whether or not their product works.

An aspect of Parexel that makes the firm outstanding is patient-oriented service. The company ensures that all clinical research is carried out with the consideration of the patients' requirements. The firm strives to ensure that clinical trials are accessible. Moreover, Parexel uses innovative technology such as artificial intelligence to ensure faster and efficient research processes.

Currently, Parexel offers its services to support the research of diseases ranging from cancers, neurology, infectious diseases, orphan diseases, among others. In contributing to the development of these drugs, Parexel plays an important role in healthcare in various countries.

Job Summary

Initiating CRA 2 (iCRA II) assumes the responsibility for performing certain important functions in the pre-clinical research stage of clinical trials. A lot of approval procedures, documentation, and preparation for the clinical trial should be conducted prior to launching the research of a novel drug on patients.

As iCRA II, you are responsible for communication between Parexel and medical institutions that are going to participate in the research program. Together with other specialists, you will help to prepare research sites for clinical trials. This process includes submission of regulatory documents, working with ethical committee, reviewing of study documents, etc.

As initiating CRA II, you are responsible for developing a relationship with research site partners and solving potential problems, maintaining timelines of activities, and compliance with international standards of clinical research, like ICH-GCP. Being attentive to details will be your key advantage.

To put it simply, the iCRA II plays the part of “setting up the stage” before the start of any clinical trials. The failure of this responsibility means that sites will not be ready to begin their enrolment process. Therefore, iCRA II is perfect for anyone who wants to get involved in clinical research, regulatory affairs, site initiation processes, and pharmaceuticals worldwide.

Key Responsibilities

• Develop and prepare detailed EUCTR submission packages for large Phase II/Phase III clinical studies

• Manage clinical study start-up activities in multiple countries/sites

• Support the planning, execution, monitoring, and resolution of clinical study start-up activities

• Collaborate with internal study team members, vendors, and sites to ensure the smooth progress of clinical trial submissions

• Prepare clinical study documents through trial management system such as CTMS/TMF

• Facilitate adherence of clinical study start-up to the ICH-GCP/EUCTR/IVDR guidelines

Qualifications and Skills

Must-Have Skills

• A bachelor's degree

• 3-4 years of experience in clinical research

• Clinical drug development and study start-up experience

• ICH-GCP, EUCTR, and IVDR regulatory guidelines knowledge

• Project management fundamentals

• Basics of CTMS, TMF, Microsoft Word, Excel, PowerPoint, and Project

Bonus Skills

• Vendor management experience

• Large Phase II/Phase III trial experience

• Experience in managing clinical trial studies in multiple countries/sites

• Data-driven approach to planning, executing and problem solving

• Willingness to travel 25%

Soft Skills and Personal Qualities

• Excellent communication skills

• Interpersonal skills and Leadership

• Proactive and self-disciplined approach to tasks

• Time management and adherence to deadlines

• Prioritizing and organizing skills

• Ability to facilitate study team collaboration

• Ability to work in cross functional teams

Salary and Benefits

The annual salary range for an Initiation CRA II at Parexel, India, is between ₹9 LPA and ₹15 LPA. Your remuneration would depend on your experience, expertise, and knowledge in clinical research.

Career Growth Opportunities

These positions may get into advanced site start-up positions, clinical trial management, regulatory affairs, clinical operations, and even global study management positions over time. It is not the job title itself that makes the experience valuable, but the experience managing clinical trial start-up activities in multiple countries and research sites.

Team Structure

You will interact with site start-up specialists, clinical operations specialists, regulatory specialists, project managers, and vendors for your study projects. Your interaction will mainly be associated with coordination with research sites, sponsors, and internal cross-functional teams to initiate studies.

Why This Role Stands Out

At first glance, this job can seem like a site start-up position; however, this will provide experience in regulatory submissions, global clinical trials, and international study management. By gaining strong experience in site start-up, you develop skills that are highly sought after in the whole industry.

How to Apply

For you to be able to secure this job opportunity, you should add keywords to your CV about clinical research, the start-up process, submission procedures, EUCTR, ICH-GCP, CTMS, TMF, clinical trial coordination, project management, vendor management, and inter-functional collaboration. It is important that you demonstrate your ability in managing time, solving problems, documentation management, and dealing with global partners in your CV.

Hit the apply button.

Best of luck!