Required Clinical Reserach Asssociate

Shree Dhootapapeshwar; Mumbai; On-site; INR 600,000 - 900,000; Full time

Job summary

Shree Dhootapapeshwar, located in Mumbai, is seeking a skilled professional to manage clinical trials. Key responsibilities include developing protocols, monitoring trial sites, and ensuring compliance with regulatory guidelines.

The ideal candidate holds a Bachelor’s or Master’s degree in relevant fields, with proven clinical research experience. Strong organizational and communication skills are essential for success. Join us in advancing clinical research while protecting participant rights.

Qualifications

• Proven experience in clinical research or clinical trial management.
• Strong knowledge of GCP and regulatory guidelines.
• Proficiency in statistical analysis and research methodologies.

Responsibilities

• Develop and write clinical trial protocols and research plans.
• Manage recruitment and training of clinical trial staff.
• Oversee documentation processes and ensure compliance with SOPs.

Skills

Clinical trial management

Statistical analysis

Documentation skills

Stakeholder management

Communication skills

Education

Bachelors/Master’s degree in Life Sciences, Pharmacy, Medicine

PhD preferred

Job description

Key Responsibilities:

• Develop, design, and write clinical trial protocols and experimental research plans; present proposals to the Steering Committee for approval.
• Identify, evaluate, and select clinical trial sites/institutes; manage site initiation, monitoring, and close-out activities.
• Liaise with Ethics Committees to ensure the rights, safety, and well-being of study participants are protected at all times.
• Recruit qualified clinical trial staff and ensure appropriate onboarding and training in line with study requirements and regulatory standards.
• Manage procurement, tracking, approval, and utilization of clinical trial materials and investigational products.
• Oversee documentation processes including drug dispensing, inventory management, and reconciliation in compliance with SOPs.
• Monitor subject recruitment, enrollment, and study follow-up to ensure adherence to protocols and regulatory guidelines.
• Ensure timely and accurate documentation and reporting of adverse events (AEs) and serious adverse events (SAEs); coordinate with investigators for regulatory reporting.
• Conduct clinical and experimental research activities, including data collection, statistical analysis, and interpretation of study results.
• Prepare monitoring visit reports, clinical study reports, and maintain proper documentation and archiving as per regulatory and SOP requirements.
• Lead scientific report writing, manuscript development, and publication of research findings in peer-reviewed journals.
• Negotiate budgets and contracts with clinical trial sites and vendors; ensure cost efficiency and timely, accurate payments.

Qualifications & Requirements:

• Bachelors/Master’s degree in Life Sciences, Pharmacy, Medicine, or related field (PhD preferred).
• Proven experience in clinical research, clinical trial management, or related domain.
• Strong knowledge of GCP, regulatory guidelines, and clinical trial processes.
• Proficiency in statistical analysis and research methodologies.
• Excellent documentation, report writing, and scientific publication skills.
• Strong organizational, communication, and stakeholder management abilities.