Inhouse CRA

NovoBliss Research®️ Private Limited; Ahmedabad District; On-site; INR 500,000 - 900,000; Full time

Job summary

NovoBliss Research® Private Limited in Ahmedabad, India, seeks an Inhouse Clinical Research Associate (CRA) to support planning, initiation, and ongoing management of clinical studies. The role covers site start-up, essential document maintenance, and regulatory submissions with a focus on GCP compliance.

You will provide remote monitoring support, track site performance, review CRFs and source documents, ensure timely data entry and query resolution, and collaborate with project managers,

Qualifications

• Strong understanding of clinical research processes, ICH-GCP guidelines, and regulatory requirements.
• Experience in clinical trial coordination, site communication, and remote monitoring support for safety and efficacy studies.
• Proficiency in documentation, data management, and use of electronic data capture (EDC) or clinical trial management systems (CTMS).
• Ability to review source data, CRFs, and study records with attention to detail and accuracy.
• Effective written and verbal communication skills for collaboration with cross-functional teams and investigators.
• Organizational and time-management skills to handle multiple studies, timelines, and priorities in a fast-paced environment.
• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or a related field; clinical research certification is an advantage.
• Prior experience in a CRO or clinical research setting is preferred; familiarity with consumer healthcare, nutraceutical, or cosmetic studies is beneficial.

Responsibilities

• Support planning, initiation, and ongoing management of clinical studies.
• Coordinate study start-up activities and maintain essential documents.
• Assist regulatory submissions and audit readiness.
• Provide remote monitoring support and track site performance metrics.
• Review source documents and CRFs; ensure timely data entry and query resolution.
• Collaborate with project managers, investigators, and site staff to ensure protocol compliance.

Skills

Clinical research

GCP knowledge

Regulatory understanding

Documentation

Communication

Time management

Education

Bachelor’s or Master’s in Life Sciences/Pharmacy/Nursing

Clinical Research Certification (advantage)

Tools

EDC

CTMS

Job description

Company Description

NovoBliss Research® Private Limited, based in Ahmedabad, India, is a CDSCO-registered and ISO 9001:2015 certified Contract Research Organization specializing in scientifically validated clinical safety and efficacy studies for consumer healthcare products. The organization conducts research across nutraceuticals, pharmaceuticals, cosmetics, dental, OTC, and personal healthcare sectors, offering end-to-end clinical solutions for diverse brands. As a member of the Advertising Standards Council of India (ASCI) and the Indian Society for Clinical Research (ISCR), NovoBliss upholds rigorous ethical and regulatory standards. Founded by Dr. Nayan Patel and Dr. Maheshvari Patel, the company focuses on global clinical research driven by scientific excellence, innovation, and integrity. Through robust study design, streamlined data collection, and insightful analysis, NovoBliss delivers precise, efficient research with a strong commitment to quality and safety.

Role Description

The Inhouse Clinical Research Associate (CRA) is a full-time, on-site role based in Ahmedabad. The individual in this role will support the planning, initiation, and ongoing management of clinical studies, including coordinating study start-up activities, maintaining essential documents, and assisting in regulatory submissions. Day-to-day responsibilities include remote monitoring support, tracking site performance metrics, reviewing source documents and case report forms (CRFs), and ensuring timely data entry and query resolution. The role involves close collaboration with project managers, investigators, and site staff to maintain protocol compliance, uphold Good Clinical Practice (GCP) standards, and support audit and inspection readiness. The Inhouse CRA will also contribute to study documentation, meeting minutes, and internal reporting to help keep projects on schedule and aligned with quality requirements.

Qualifications

• Strong understanding of clinical research processes, ICH-GCP guidelines, and applicable regulatory requirements.
• Experience in clinical trial coordination, site communication, and remote monitoring support for safety and efficacy studies.
• Proficiency in documentation, data management, and use of electronic data capture (EDC) or clinical trial management systems (CTMS).
• Ability to review source data, CRFs, and study records with attention to detail and accuracy.
• Effective written and verbal communication skills for collaboration with cross-functional teams and investigators.
• Organizational and time-management skills to handle multiple studies, timelines, and priorities in a fast-paced environment.
• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, or a related field; clinical research certification is an advantage.
• Prior experience in a CRO or clinical research setting is preferred; familiarity with consumer healthcare, nutraceutical, or cosmetic studies is beneficial.