Clinical Research Associate

Biosphere Clinical Research Pvt. Ltd.is looking for a Clinical Research Associate (CRA).

Clinical Research Associate (CRA) – Job Description

Location: Thane, Maharashtra
Company: Biosphere Clinical Research Pvt Ltd

Job Summary:

We are seeking a highly motivated and detail-oriented Clinical Research Associate (CRA) to join our dynamic team at Biosphere Clinical Research Pvt Ltd. As a CRA, you will be responsible for managing and monitoring clinical trials to ensure they are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP guidelines, and applicable regulatory requirements.

Key Responsibilities:

• Conduct site selection, initiation, routine monitoring, and close-out visits in accordance with the study monitoring plan.
• Ensure the rights, safety, and well-being of trial subjects are protected.
• Verify the accuracy, completeness, and integrity of clinical trial data.
• Ensure timely collection and review of essential regulatory documents.
• Provide training and ongoing support to investigative sites.
• Identify and escalate protocol deviations, safety issues, and non-compliance.
• Maintain effective communication with site staff, sponsor, and internal project team.
• Prepare and submit monitoring visit reports within the required timelines.
• Collaborate with cross-functional teams including project management, data management, and regulatory affairs.
• Assist in the resolution of data queries and support site readiness for audits and inspections.

Qualifications:

• Master’s degree in pharmacy, or a related field (Master’s or equivalent is a plus).
• Minimum 2-5 years of experience in clinical research, preferably within a CRO environment.
• Sound knowledge of ICH-GCP guidelines and regulatory requirements.
• Strong organizational and time-management skills.
• Excellent verbal and written communication skills.
• Willingness to travel frequently
• Proficiency in Microsoft Office and clinical trial management systems (CTMS/eTMF).

Preferred Qualifications:

• Certification in clinical research (e.g., ACRP, SOCRA).
• Experience with Phase I–IV trials across multiple therapeutic areas.
• Familiarity with electronic data capture (EDC) systems.

Job Type: Full-time

Pay: ₹20,000.00 - ₹50,000.00 per month

Work Location: In person