Clinaarc is hiring a Clinical Research Associate (CRA) in Mumbai/Pune. Min. 3 years of medical device monitoring exp. Knowledge of GCP & ISO 14155 required. Apply now!
Job Title: Clinical Research Associate (CRA) – Medical Devices
Location: Mumbai, Pune, Maharashtra, India
Experience: 3+ Years
Industry: Medical Devices / Clinical Research
About Clinaarc
Clinaarc is a dynamic and growing name in the clinical research industry, dedicated to advancing medical science and improving patient outcomes. We specialize in robust and ethical clinical trials, with a sharp focus on the innovative medical device sector. Our team is passionate about bringing cutting-edge medical technologies to market by ensuring the highest standards of data integrity, patient safety, and regulatory compliance. Joining Clinaarc means becoming part of a collaborative culture that values expertise, professionalism, and career growth.
Job Description (JD)
Are you a dedicated Clinical Research Associate (CRA) with a passion for medical device innovation? Clinaarc is seeking an experienced professional to monitor and manage clinical trial sites, ensuring the successful execution of our groundbreaking medical device studies.
In this pivotal role, you will be the main line of communication between the company and clinical investigation sites. Your expertise in clinical research monitoring and deep understanding of regulatory requirements will be crucial in maintaining the highest quality standards throughout the study lifecycle.
Key Responsibilities:
As a Clinical Research Associate (CRA), your day-to-day activities will include:
- Conducting and managing site initiation, monitoring, and close-out visits effectively.
- Ensuring strict adherence to the study protocol, company SOPs, GCP (Good Clinical Practice), and ISO 14155 standards.
- Performing source data verification (SDV) to guarantee the accuracy, completeness, and consistency of collected data.
- Safeguarding patient rights and well-being by verifying proper informed consent process and monitoring subject safety.
- Maintaining and updating the Trial Master File (TMF) and other essential documents to ensure audit readiness.
- Building and maintaining strong relationships with principal investigators, site coordinators, and internal cross-functional teams.
- Preparing detailed monitoring reports, follow-up letters, and study documentation in a timely manner.
- Proactively identifying, tracking, and assisting in the resolution of study-related issues and deviations.
Qualifications & Skills
To excel in this CRA career opportunity, you should possess:
Education:
- Bachelor’s degree or Master’s degree in Life Sciences, Pharmacy, Biomedical Engineering, Nursing, MBBS, BDS, or a related field.
Experience:
- A minimum of 3 years of experience working as a Clinical Research Associate (CRA).
- Proven and hands-on experience in medical device clinical research and site monitoring is essential.
Knowledge & Skills:
- In-depth knowledge of GCP guidelines, ISO 14155, and other regulatory requirements for medical devices in India.
- Exceptional communication skills and strong technical documentation skills.
- Outstanding organizational and time-management abilities, with a keen eye for detail.
- Willingness and ability to travel to clinical sites as required by the study needs.
How to Apply
If you are a motivated professional looking for a rewarding CRA job in Mumbai or Pune, we would love to hear from you.
Please send your updated resume/CV to hr@clinaarc.com with the subject line