Key Responsibilities:
- Site Monitoring: Conduct site monitoring visits (selection, initiation, monitoring, close-out) as per Good Clinical Practice (GCP) and contracted scope of work.
- Subject Recruitment: Collaborate with sites to develop and track recruitment plans aligned with project needs.
- Protocol Management: Administer study protocol and training, maintain communication with sites, and manage project expectations and issues.
- Quality Assurance: Evaluate study site practices for protocol compliance and escalate quality issues.
- Study Progress Management: Track regulatory submissions, recruitment, case report form completion, data query generation, and resolution.
- Documentation: Ensure proper filing of site documents in the Trial Master File (TMF) and Investigator’s Site File (ISF) per GCP and regulatory requirements.
- Communication: Prepare visit reports, follow-up letters, and other necessary documentation.
- Collaboration: Work with study team members to support project execution and subject recruitment plans.
Qualifications:
- Education: B.Pharm/M.Pharm/BDS/BAMS/BHMS required.
- Experience: 1-2 years of on-site monitoring experience.
- Knowledge: Proficient in clinical research regulatory requirements, including GCP and ICH guidelines.
- Skills: Proficiency in Microsoft Word, Excel, PowerPoint; strong organizational, problem-solving, communication skills in English.
- Other: Ability to manage time and finances effectively and maintain good working relationships.
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