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Clinical Research Coordinator

2 months ago

Hyderabad, India Continental Hospitals Full time

We're looking for a highly skilled Clinical Research Coordinator with a strong background in managing clinical trials. The ideal candidate will have 5+ years of experience in domestic and international trials, ensuring compliance with statutory guidelines and regulations.


Key Responsibilities:

  • Coordinate clinical trials from initiation to closure.
  • Manage study protocols, amendments, and documentation.
  • Ensure compliance with ICH-GCP, FDA, and local regulations.
  • Conduct site feasibility assessments and site initiation visits.
  • Monitor data acquisition, quality, and reporting.
  • Develop and manage study budgets and contracts.
  • Collaborate with investigators, sponsors, and CROs.
  • Maintain accurate records and trial master files.


Requirements:

  • Bachelor's degree in Life Sciences, Pharmacy, Nursing, or related field.
  • Minimum 5 years of experience in clinical research coordination.
  • Proven experience in managing domestic and international clinical trials.
  • In-depth knowledge of:

- ICH-GCP guidelines

- FDA regulations

- Local regulatory requirements

- GCP compliance

- Data management and reporting


Desirable Qualifications:

  • Certification in Clinical Research (CCRA, CCRP, etc.).
  • Experience with CTMS, EDC, and other research software.
  • Familiarity with medical writing and publishing.
  • Strong analytical and problem-solving skills.