Clinical Research Associate

1 week ago

Thane, India BIOSPHERE CLINICAL RESEARCH PVT LTD & Sprutha Impex Pvt Ltd Full time

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.
- 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.

Pay: ₹20,000.00 - ₹40,000.00 per month

Schedule:

- Day shift

Work Location: In person

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