JSS Medical Research is a leading contract research organization (CRO) specializing in clinical research services. With a strong global presence, JSS Medical Research is known for its expertise in conducting high-quality clinical trials, ensuring compliance with regulatory guidelines and Good Clinical Practices (GCP). The company is committed to providing innovative solutions in the healthcare and pharmaceutical industries.
Responsibilities in the Job
As a Clinical Research Associate (CRA) at JSS Medical Research, your primary responsibilities will include:
- Site Selection & Qualification: Conducting initial assessments of clinical trial sites to ensure they meet study requirements.
- Study Initiation & Training: Meeting with clinical investigators and site staff to ensure they understand all aspects of the study protocol and guidelines.
- Regulatory Compliance: Ensuring submission of Ethics Committee (EC) dossiers, obtaining approvals, and initiating site visits.
- Patient Enrollment & Monitoring: Tracking and monitoring patient recruitment, ensuring compliance with the study protocol.
- On-site & Remote Monitoring: Conducting regular site monitoring visits to review source documents, case report forms (CRFs), patient diaries, and investigator site binders.
- Quality Assurance: Identifying and mitigating bottlenecks at sites, ensuring data integrity, and preparing sites for audits and inspections.
- Study Closure & Archival: Ensuring all data collection is completed, study supplies are returned, and documents are archived appropriately.
- Travel Requirements: The role involves 50-70% travel to various clinical trial sites.
Qualifications
To be eligible for the Clinical Research Associate role, candidates must have:
- Education: Postgraduate degree in Life Sciences, Science, BDS, MDS, BAMS, or BHMS.
- Experience: Minimum of 2 years of experience in Clinical Research, specifically in onsite monitoring.
- Regulatory Knowledge: Strong understanding of Good Clinical Practices (GCP) and Good Documentation Practices (GDP).
Skills Required
Candidates applying for this role should possess:
- Technical Skills: Proficiency in Microsoft Office (Excel, Word, PowerPoint).
- Analytical & Problem-Solving Abilities: Ability to identify and resolve site-related challenges effectively.
- Communication & Interpersonal Skills: Strong ability to interact with investigators, site staff, and regulatory authorities.
- Attention to Detail: Ensuring compliance with protocols, documentation, and regulatory requirements.
- Flexibility & Adaptability: Willingness to travel extensively and manage multiple sites.
How to Apply
Interested candidates can apply for the Clinical Research Associate – Mumbai position at JSS Medical Research by following these steps:
- Online Application: Visit the official JSS Medical Research careers page or job portals where the position is listed.
- Submit Resume: Upload your updated resume highlighting your experience in clinical research and monitoring.
- Interview Process: Shortlisted candidates will be contacted for an interview, which may include technical and HR rounds.
- Final Selection: Successful candidates will receive an offer letter and further onboarding details.
Job Location
- Mumbai (Thane)
- Chennai
- Delhi
