Clinical Research Associate
7 months ago
**Job Overview**:
As a Clinical Research Associate (CRA), your primary responsibility is to ensure the smooth and ethical conduct of clinical trials. You will be responsible for monitoring and managing clinical trial sites, ensuring compliance with protocols, regulations, and company procedures. CRAs play a crucial role in safeguarding the rights and well-being of study participants while collecting high-quality data to support the development of new medical treatments.
**Key Responsibilities**:
**Site Monitoring**:Conduct regular site visits to monitor protocol compliance, data accuracy, and regulatory adherence.
Verify the source documentation, including medical records, against the case report forms (CRFs) to ensure data integrity.
**Regulatory Compliance**:Ensure that all aspects of the clinical trial adhere to relevant regulatory requirements and guidelines.
Assist in preparing and submitting regulatory documents to health authorities and ethics committees.
**Data Collection and Management**:Collaborate with site personnel to resolve data discrepancies and ensure accurate data collection.
Review and track study progress, ensuring timely and quality data submission.
**Safety Oversight**:Monitor and report adverse events, ensuring timely reporting to regulatory authorities and sponsors.
Work closely with investigators to implement safety measures and protocol amendments.
**Communication and Collaboration**:Maintain effective communication with investigators, site staff, and project team members.
Collaborate with cross-functional teams, including data management, statistics, and medical monitoring.
**Training and Support**:Provide training to site staff on study protocols, data collection procedures, and regulatory requirements.
Offer support and guidance to investigators and site personnel throughout the study.
**Documentation**:Maintain accurate and up-to-date trial documentation, including site files, monitoring reports, and correspondence.
Ensure all essential documents are collected and filed appropriately.
**Qualifications**:
- Bachelor's or advanced degree in a relevant field (life sciences, pharmacy, nursing, etc.).
- Prior experience as a Clinical Research Associate or in a similar role.
- Good understanding of ICH-GCP guidelines, local regulations, and industry best practices.
- Strong communication and interpersonal skills.
- Attention to detail and ability to work independently and in a team.
**Job Types**: Full-time, Permanent, Fresher
**Salary**: ₹21,966.94 - ₹30,000.00 per month
**Benefits**:
- Health insurance
- Provident Fund
Schedule:
- Day shift
- Morning shift
Supplemental pay types:
- Performance bonus
- Yearly bonus
Ability to Commute:
- Bangalore, Karnataka (required)
Ability to Relocate:
- Bangalore, Karnataka: Relocate before starting work (required)
**Speak with the employer**
+91 7676759293
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