About Lambda & Your Role
Lambda Therapeutic Research is a full-service global Clinical Research Organization (CRO) headquartered in Ahmedabad, with strategic operations across North America, Europe, and the UK. We partner with innovator, biotech, and generic pharmaceutical companies worldwide to deliver end-to-end clinical research services.
We are seeking a dedicated Clinical Research Associate (CRA) to join our Clinical Trial Management team in Ahmedabad. In this vital on-site role, you will be the primary link between Lambda and our investigative sites, ensuring the integrity, compliance, and smooth execution of clinical trials. You will ensure patient safety, data accuracy, and protocol adherence through meticulous monitoring and collaboration.
Key Responsibilities
As a CRA, you will be responsible for the following core activities:
- Site Management & Monitoring: Perform all types of study site visits—Site Selection (SSV), Site Initiation (SIV), Routine Monitoring (SMV), and Site Close-Out (SCOV)—as per the assigned project's scope and plan.
- Training & Compliance: Provide comprehensive protocol and study procedure training to site staff. Ensure strict compliance with the study protocol, GCP guidelines, and all regulatory requirements at the site level.
- Documentation & Data Quality: Maintain essential documents by updating the Site Master File (SMF). Perform thorough source data verification (SDV) to ensure the accuracy and completeness of clinical trial data.
- Patient Recruitment & Support: Work closely with site personnel to support and track patient screening, recruitment, and follow-up activities to meet enrollment timelines.
- Logistics & Communication: Ensure the timely availability of study materials and investigational medicinal product (IMP) at the site. Serve as the primary communication link between the Lambda project team and the investigative site, facilitating smooth information flow and issue resolution.
Qualifications & Requirements
Education
- A degree in MSc, M.Pharm, B.Pharm, BAMS, BHMS, Dentistry, or a similar medical/life sciences field.
Experience
- A minimum of 5 years of total experience within the pharmaceutical or clinical research industry.
- At least 1 year of hands-on experience working specifically as a Clinical Research Associate (CRA), conducting on-site monitoring activities.
Core Competencies
We are looking for a professional who demonstrates:
- Technical Knowledge & Accountability: Strong understanding of ICH-GCP guidelines and clinical trial processes. Takes ownership of site quality and compliance.
- Initiative & Work Ethic: Self-motivated, proactive in identifying and resolving site issues, and committed to delivering high-quality work.
- Communication & Interpersonal Skills: Excellent verbal and written communication skills to effectively interact with site staff and internal teams. Possesses strong presentation abilities.
- Planning & Organizing: Flexible and able to efficiently plan, organize, and prioritize multiple site responsibilities and visits.
- Team & Culture Fit: A collaborative team player who aligns with Lambda’s values of quality, integrity, and partnership.
Ready to advance your career with a leading global CRO?
If you are a motivated CRA looking to contribute to meaningful clinical research and grow within an international organization, we encourage you to apply.
Apply now for the CRA position in Ahmedabad.
