Clinical Research Associate

4 days ago

Pune District Maharashtra, India Globe Healthcare Full time

**Site Monitoring**:Conducting regular visits to clinical trial sites to ensure study protocols are followed accurately, including patient recruitment, data collection, and informed consent procedures.
- **Data Quality Assurance**:Reviewing and verifying clinical trial data for accuracy and completeness, identifying and resolving discrepancies, and performing quality audits.
- **Study Protocol Adherence**:Ensuring all study activities comply with the established protocol, Good Clinical Practice (GCP) guidelines, and regulatory requirements.
- **Patient Recruitment and Screening**:Assisting clinical sites with patient recruitment, screening, and eligibility determination for clinical trials.
- **Investigator Communication**:Maintaining open communication with study site investigators, addressing any concerns or issues arising during the trial.
- **Regulatory Compliance**:Staying updated on relevant regulatory requirements and ensuring clinical trials are conducted in compliance with local and international regulations.
- **Report Generation**:Preparing and submitting accurate clinical trial reports to the study sponsor, including progress updates, safety reports, and study completion reports.
- **Training and Education**:Providing training to clinical site staff on study protocols, data collection procedures, and GCP guidelines.
- **Study Start-up and Closeout Activities**:Participating in the initiation and closure of clinical trial sites, including necessary documentation and administrative tasks.
- **Risk Management**:Identifying potential risks associated with clinical trials and implementing appropriate mitigation strategies.

**Key Skills for a CRA**:

- Strong understanding of clinical trial methodologies and GCP guidelines
- Excellent communication and interpersonal skills to interact with investigators and site staff
- Detail-oriented with strong analytical skills to review and interpret clinical data
- Ability to work independently and manage multiple projects simultaneously
- Proficiency in clinical trial management systems and electronic data capture (EDC)

Pay: ₹10,786.67 - ₹31,932.52 per month

Work Location: On the road

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