Are you a dedicated and talented professional seeking to advance your career in clinical research? Novaspire Biosciences, a leading healthcare company specializing in Pharmacovigilance, Clinical Research, and Bioavailability/Bioequivalence studies, is currently seeking a Clinical Research Associate (CRA) to join their dynamic team in Bengaluru, Karnataka, India. If you possess a passion for promoting patient safety and public health through innovative solutions, this may be the perfect opportunity for you!
About Novaspire Biosciences
Novaspire Biosciences Private Limited is at the forefront of enhancing patient safety and promoting public health. With a focus on the pharmaceutical and biotechnology industries, the company offers a comprehensive range of services, including Pharmacovigilance, Clinical Research Consulting, and Regulatory Affairs Solutions. Novaspire prides itself on its team of experienced professionals who are dedicated to improving healthcare outcomes through meticulous and compliant methodologies.
Key Responsibilities of the Clinical Research Associate Role
As a Clinical Research Associate at Novaspire Biosciences, you will play a vital role in ensuring the integrity and accuracy of clinical trials. Some of the key responsibilities include:
Monitoring Compliance
- Ensure compliance with study protocols, standard operating procedures, and Good Clinical Practice (GCP) guidelines.
Conducting Site Visits and Training
- Conduct regular site visits to monitor trial activities and data collection, while providing training to site staff on study protocols and GCP guidelines.
Data Review and Analysis
- Review and analyze clinical trial data to ensure accuracy and completeness, maintaining the highest standards of data quality.
Managing Study Logistics
- Develop and maintain study timelines and budgets, managing trial supplies and drug accountability effectively.
Liaison Activities
- Act as a liaison between study sites, sponsors, and regulatory agencies to ensure seamless communication and address any arising issues.
Required Qualifications for Applicants
To be considered for this exciting opportunity at Novaspire Biosciences, applicants should meet the following qualifications:
- A Bachelor’s or Master’s degree in Pharmacy or a related field.
- A minimum of 1 year of experience in a similar role within clinical research.
- A strong understanding of regulatory requirements and guidelines, including GCP and ICH.
- Certification in clinical research, such as the Association of Clinical Research Professionals (ACRP) certification, is highly preferred.
- Proficiency in clinical trial data management systems and electronic data capture tools.
- Hands-on experience with site selection, initiation, management, and monitoring activities.
- An exceptional attention to detail and accuracy in data management is essential.
Preferred Skills and Qualifications
In addition to the required skills, candidates with the following qualifications will have a competitive advantage:
- A foundational understanding of pharmacology and drug development processes.
- Familiarity with medical terminology and anatomy.
- Excellent project management and leadership skills, with an emphasis on accurate detail.
- The ability to collaborate effectively with cross-functional teams and study staff.
Why Work at Novaspire Biosciences?
Joining Novaspire Biosciences means becoming part of a committed team that values innovation, integrity, and a collaborative spirit. Employees are encouraged to contribute ideas and drive improvements, making a real difference in the lives of patients. The company offers a supportive work environment that fosters professional growth and development.
