Clinical Research Nurse

2 weeks ago


Bengaluru, Karnataka, India Syngene Full time
Job Description

Job Title: Clinical Research Nurse

Job Summary: We are seeking a highly skilled and experienced Clinical Research Nurse to join our team at Syngene. The successful candidate will be responsible for coordinating and conducting clinical trials, ensuring the highest standards of patient care and data quality.

Key Responsibilities:

  • Coordinate and conduct clinical trials, ensuring compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.
  • Develop and maintain strong relationships with investigators, site staff, and other stakeholders to ensure successful trial execution.
  • Collaborate with cross-functional teams to identify and mitigate risks, and implement corrective actions as needed.
  • Ensure accurate and timely data collection, management, and reporting, including adverse event reporting.
  • Provide training and support to site staff on clinical trial procedures and Good Clinical Practice (GCP) guidelines.
  • Conduct site initiation visits, monitoring visits, and close-out visits to ensure trial compliance and quality.
  • Develop and maintain trial-related documents, including informed consent forms, case report forms, and study protocols.
  • Ensure compliance with regulatory requirements, including ICH-GCP, 21 CFR Part 11, and HIPAA.
  • Participate in audits, inspections, and quality assurance activities to ensure trial quality and compliance.
  • Stay up-to-date with regulatory requirements, industry trends, and best practices in clinical research.

Requirements:

  • Registered Nurse (RN) degree and current licensure in good standing.
  • Minimum 2 years of experience in clinical research, preferably in a pharmaceutical or biotechnology company.
  • Strong knowledge of clinical trial regulations, Good Clinical Practice (GCP) guidelines, and ICH-GCP.
  • Excellent communication, interpersonal, and project management skills.
  • Ability to work independently and as part of a team.
  • Proficiency in Microsoft Office, including Word, Excel, and PowerPoint.
  • Ability to travel up to 20% of the time.

What We Offer:

  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.
  • Recognition and rewards for outstanding performance.


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