Job Title: Clinical Research Associate II (CRA-II)
Location: Mumbai
Summary:
IQVIA, a leading global provider of advanced analytics, technology solutions, and contract research services to the life sciences industry, is seeking a highly motivated and experienced Clinical Research Associate II (CRA-II) to join our dynamic team in Mumbai. As a CRA-II, you will play a crucial role in ensuring the integrity and quality of clinical trials through on-site monitoring, data verification, and collaboration with study sites. This is an excellent opportunity for a driven individual with a strong understanding of ICH-GCP guidelines and a passion for advancing healthcare. If you are a detail-oriented professional with a proven track record of success in clinical trial monitoring, we encourage you to apply.
About IQVIA:
IQVIA (NYSE:IQV) is a world leader in using data, technology, advanced analytics and human expertise to help customers drive healthcare forward. IQVIA provides intelligent and actionable solutions to the biopharmaceutical, medical device and healthcare industries, empowering them to make better decisions and ultimately, improve patient outcomes.
Job Responsibilities:
As a Clinical Research Associate-II, your primary responsibilities will include:
- On-site Monitoring: Conducting comprehensive on-site monitoring visits in accordance with ICH-GCP guidelines, sponsor Standard Operating Procedures (SOPs), and study protocols.
- Source Data Verification (SDV): Performing thorough SDV to ensure the accuracy, completeness, and consistency of clinical trial data.
- Site Performance Assessment: Evaluating site performance and adherence to study protocols, identifying areas for improvement, and implementing corrective actions.
- Documentation and Reporting: Accurately documenting monitoring findings and follow-up actions in detailed monitoring reports, ensuring clear and concise communication of site performance.
- Collaboration and Communication: Effectively coordinating with investigators, site staff, and project teams to facilitate seamless communication and efficient trial execution.
- Safety Reporting: Ensuring timely and accurate reporting of adverse events and other safety-related information in compliance with regulatory requirements.
- Audit and Inspection Readiness: Supporting site preparedness for audits and regulatory inspections by ensuring adherence to relevant guidelines and regulations.
- Trial Master File (TMF) Management: Maintaining accurate and up-to-date TMF documentation, ensuring compliance with record-keeping requirements.
Eligibility & Qualifications:
To be considered for this CRA-II position, candidates must meet the following requirements:
Required Education:
- Bachelor of Pharmacy (B.Pharm) / Master of Pharmacy (M.Pharm) / Doctor of Pharmacy (Pharm D) / Bachelor of Dental Surgery (BDS) / Bachelor of Homeopathic Medicine and Surgery (BHMS) / Bachelor of Ayurvedic Medicine and Surgery (BAMS)
Required Experience:
- Minimum of 2+ years of experience in on-site monitoring of clinical trials.
- Proven track record of completing 90+ on-site interim monitoring visits.
- In-depth knowledge of clinical trial protocols, Good Clinical Practice (GCP) guidelines, and relevant regulatory requirements.
- Preference will be given to candidates who are available to join immediately.
Preferred Skills:
- Excellent verbal and written communication skills, with the ability to effectively interact with a diverse range of stakeholders.
- Strong organizational skills and the ability to manage multiple study sites independently.
- Exceptional problem-solving and analytical skills, with a demonstrated ability to identify and resolve issues in a timely manner.
- Experience working with Electronic Data Capture (EDC) systems and other clinical trial software.
Benefits of Working at IQVIA:
IQVIA offers a comprehensive benefits package designed to support the health, well-being, and professional development of our employees. As a CRA-II at IQVIA, you can expect:
- Competitive salary and performance-based incentives.
- Opportunities to work with leading global sponsors on innovative clinical trials.
- Professional development and training opportunities to enhance your skills and advance your career.
- A supportive and inclusive work environment that fosters collaboration and innovation.
- Clear career progression paths, with opportunities to advance to Senior CRA, Lead CRA, or Project Management roles.
How to Apply:
If you meet the qualifications outlined above and are interested in joining our team as a Clinical Research Associate-II in Mumbai, we encourage you to apply. Please submit your updated curriculum vitae (CV) to [[email protected]]. We look forward to reviewing your application!