Job Title: Clinical Research Associate (CRA) – Multiple Locations
Summary:
Maiora is seeking highly motivated and experienced Clinical Research Associates to join our expanding team across India. This is an excellent opportunity for individuals with a strong foundation in on-site monitoring and a desire to contribute to global clinical trials. As a CRA, you will be responsible for ensuring the integrity and compliance of clinical trial sites, adhering to GCP, ICH guidelines, and regulatory requirements. Immediate joiners are highly encouraged to apply!
About Maiora:
Maiora is a dynamic and growing Contract Research Organization (CRO) committed to providing high-quality clinical research services to our clients. We offer a supportive and collaborative work environment where employees can thrive and develop their careers. We are dedicated to advancing medical research and improving patient outcomes.
Job Locations:
We have immediate openings in the following metro cities:
- Bangalore
- Chennai
- Mumbai
- Pune
- Delhi
Key Responsibilities:
As a Clinical Research Associate, your primary responsibilities will include:
- Site Management: Conducting comprehensive site monitoring visits, including selection, initiation, routine monitoring, and close-out visits.
- Compliance Assurance: Ensuring strict adherence to Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and all applicable regulatory requirements throughout the clinical trial process.
- Subject Recruitment: Supporting and actively tracking subject recruitment strategies at assigned clinical trial sites, working collaboratively with site staff to meet enrollment goals.
- Training and Education: Delivering protocol and site training to site personnel, ensuring a thorough understanding of study requirements and procedures.
- Data Integrity: Rigorously monitoring data quality, completeness of Case Report Forms (CRFs), regulatory approvals, and key enrollment metrics to identify and address any discrepancies or issues.
- Documentation Management: Maintaining Trial Master File (TMF) and Investigator Site File (ISF) documentation according to established global standards, ensuring accuracy, completeness, and audit readiness.
- Reporting and Communication: Preparing detailed monitoring visit reports, follow-up letters, and site correspondence, ensuring clear and concise communication of findings and recommendations.
- Issue Resolution: Identifying and escalating quality findings and implementing corrective actions to address any deviations or non-compliance issues promptly and effectively.
- Collaboration: Collaborating effectively with study teams to ensure seamless project execution and efficient resolution of any challenges that may arise.
- Financial Management (If applicable): Supporting site-level financial management activities based on Clinical Trial Agreements (CTAs), ensuring accurate tracking and reconciliation of study-related expenses.
Required Qualifications & Skills:
To be considered for this role, candidates must possess the following qualifications and skills:
- Education: Bachelor’s degree in Life Sciences, Healthcare, or a related field (preferred).
- Experience: Minimum of 1.5+ years of hands-on, on-site monitoring experience in clinical research.
- Knowledge: Comprehensive understanding of clinical trial processes, GCP guidelines, and ICH guidelines.
- Technical Skills: Proficiency in MS Word, Excel, and PowerPoint.
- Communication Skills: Exceptional written and verbal communication skills, with the ability to effectively communicate with site personnel, study teams, and management.
- Organizational Skills: Strong organizational, problem-solving, and time-management abilities, with the capacity to manage multiple tasks and prioritize effectively.
- Teamwork: Ability to work collaboratively with site teams, managers, and cross-functional groups, fostering a positive and productive work environment.
Benefits of Joining Maiora:
By joining Maiora, you will benefit from:
- Professional Growth: Opportunity to work with a respected CRO and gain exposure to global study operations, enhancing your expertise and broadening your professional network.
- Career Advancement: Clear pathways for career progression, with opportunities to advance into Senior CRA, Lead CRA, or Project Management roles based on performance and experience.
- Competitive Compensation: Competitive salary and performance-based recognition, ensuring that your contributions are valued and rewarded.
- Location Flexibility: Multi-city flexibility, allowing you to choose a location that best suits your personal and professional needs.
- Long-Term Stability: Long-term career stability in the growing and dynamic field of clinical research, with opportunities for continuous learning and development.
How to Apply:
If you meet the qualifications and are interested in this exciting opportunity, please submit your updated CV to [email protected]. We are looking for immediate joiners, so don’t delay!