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.
Apply today or reach out at kirti_k@trigent.com
