Job Description

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

Clinical Research Associate (CRA) -

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