At Indivirtus, we are more than just a contract research organization; we are partners in progress for the global pharmaceutical and biotechnology industry. Our name reflects our commitment to individualized excellence and ethical virtue in all our endeavors.
Open Job Positions: Detailed Job Description
We are currently hiring for two critical Clinical Research Associate roles. Both positions require a keen eye for detail, excellent communication skills, and a deep commitment to regulatory compliance.
1. Clinical Research Associate (Clinical Operations)
The Clinical Research Associate (CRA) in Clinical Operations is the backbone of our clinical trial monitoring activities. You will be directly involved in the management and oversight of clinical sites to ensure successful trial execution.
Key Responsibilities:
- Conduct site selection, initiation, monitoring, and close-out visits for clinical trials.
- Ensure compliance with the study protocol, ICH-GCP guidelines, SOPs, and other regulatory requirements.
- Verify the accuracy and completeness of clinical data through source data verification (SDV).
- Manage investigational product accountability and site supplies.
- Build and maintain strong, professional relationships with investigators and site staff.
- Prepare timely and accurate monitoring visit reports and follow-up letters.
- Track patient recruitment and progress at assigned sites.
Qualifications and Experience:
- Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or a related field.
- Minimum of 2+ years of independent, on-site monitoring experience as a CRA.
- In-depth knowledge of clinical research regulations and ICH-GCP guidelines.
- Strong analytical, problem-solving, and organizational skills.
- Willingness to travel extensively to clinical sites.
2. Clinical Research Associate (Bio-Analytical)
This specialized Clinical Research Associate role focuses on the Bio-Analytical laboratory aspects of clinical trials. You will act as a crucial link between the clinical sites and the labs processing pharmacokinetic (PK) and immunogenicity samples.
Key Responsibilities:
- Monitor and manage Bio-Analytical laboratories involved in clinical trials.
- Review laboratory data and reports for accuracy and compliance with the protocol.
- Ensure proper sample collection, handling, storage, and shipment from sites to designated labs.
- Verify that labs are operating in compliance with GLP (Good Laboratory Practice) and study-specific requirements.
- Resolve any queries related to laboratory data or sample discrepancies.
- Coordinate between the clinical operations team and the bio-analytical team.
Qualifications and Experience:
- Bachelor’s or Master’s degree in Biochemistry, Analytical Chemistry, Biotechnology, or a related field.
- Previous experience as a CRA with exposure to bio-analytical lab monitoring OR direct experience working in a bio-analytical lab.
- Understanding of bio-analytical techniques (e.g., HPLC, ELISA, MS) and GLP standards.
- Meticulous attention to detail with a data-driven approach.
Why Join Our Amazing Team?
- Impactful Work: Contribute to meaningful clinical research that can improve patient lives globally.
- Career Growth: We invest in our employees’ development through continuous training and clear career progression paths.
- Supportive Culture: Join a collaborative and amazing team of experts who support each other.
- Competitive Compensation: We offer a attractive salary package, benefits, and perks commensurate with your experience.
How to Apply for These CRA Positions
Ready to take the next step? Applying for these Clinical Research Associate jobs is simple.
To apply, please send your updated resume/CV to our hiring team at both email addresses:
