PAREXEL, a globally renowned biopharmaceutical service provider, is offering an exciting opportunity for professionals to join as an Initiation Clinical Research Associate II in Bengaluru, India. If you have a background in clinical research and a passion for contributing to the development of new drugs and treatments, this role is perfect for you. PAREXEL is known for its expertise in contract research, medical communications, and consulting services across various therapeutic areas, making it a leader in the pharmaceutical, biotechnology, and medical device industries.
Job Description
As an Initiation Clinical Research Associate II, you will play a pivotal role in the start-up and maintenance phases of clinical trials. Your responsibilities will include:
- Start-Up Phase:
- Acting as the primary point of contact for assigned sites, ensuring quality and timely delivery.
- Building strong relationships with investigators and site staff.
- Conducting feasibility studies, site qualification activities, and remote Qualification Visits (QVs).
- Negotiating and finalizing Confidentiality Agreements (CDAs) and Clinical Site Agreements (CSAs).
- Preparing and submitting IRB/IEC and MoH/RA applications, ensuring all regulatory documents are compliant.
- Customizing and approving Informed Consent Forms (ICFs) and managing translations as required.
- Maintenance Phase:
- Ensuring protocol adherence and resolving site-related issues.
- Conducting on-site and remote visits, including Qualification and Initiation Visits.
- Monitoring site recruitment plans and providing strategies for improvement.
- Ensuring sites are audit and inspection-ready, maintaining compliance with ICH-GCP guidelines and local regulations.
- Managing study supplies, site payments, and data quality.
Candidate Profile
To excel in this role, you should have:
- A degree in biological science, pharmacy, or a health-related discipline (or equivalent experience).
- Prior experience in site management or clinical research, with a solid understanding of clinical trial methodologies.
- Strong problem-solving skills and the ability to work independently.
- Excellent communication and presentation skills.
- Proficiency in Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS-Office tools.
- A client-focused approach, flexibility, and the ability to prioritize tasks effectively.
- Willingness to travel as per study requirements.
How to Apply
If you meet the qualifications and are ready to take on this challenging yet rewarding role, apply before the end date: 30th March 2025. Don’t miss this opportunity to be part of a leading organization that is shaping the future of healthcare.
