Trigent Software Inc. is a leading global IT solutions and services provider. With a strong presence in the healthcare and life sciences industry, Trigent leverages technology and innovation to deliver high-quality outcomes in clinical trials and research. Join a team that values integrity, collaboration, and excellence in driving impactful healthcare solutions.

Responsibilities in the Job

1. Site Selection and Initiation

• Identify and evaluate potential study sites.
• Conduct pre-study site visits to assess site capabilities.
• Initiate study sites with comprehensive protocol and GCP training.

2. Monitoring Clinical Trials

• Conduct on-site visits to ensure adherence to study protocols.
• Verify source data against Case Report Forms (CRFs).
• Document and resolve adverse events (AEs) and serious adverse events (SAEs).
• Collaborate with site staff and data management teams to address discrepancies.

3. Compliance and Quality Assurance

• Ensure clinical trial activities comply with FDA, EMA, and ICH-GCP guidelines.
• Perform site audits to maintain high-quality data.
• Supervise the handling of investigational products (IP).

4. Site Management

• Build and maintain strong relationships with investigators and site coordinators.
• Provide continuous support to resolve site-related queries.
• Monitor site performance to meet study timelines.

5. Reporting and Documentation

• Maintain updated Trial Master Files (TMF).
• Prepare detailed monitoring reports for each site visit.
• Provide progress updates to project managers and sponsors.

Qualifications

• Education: Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related fields. A master’s degree is preferred.
• Experience: Minimum 1–3 years as a Clinical Research Associate or in a similar role.
• Certification in Clinical Research (e.g., ACRP or SOCRA) is an added advantage.

Key Skills

• In-depth knowledge of GCP, ICH guidelines, and regulatory requirements.
• Attention to detail to identify and resolve data discrepancies.
• Strong verbal and written communication skills.
• Exceptional time management and organizational skills.
• Proactive problem-solving capabilities.

Application Link

Apply today or reach out at kirti_k@trigent.com