Clinical Research Coordinator 

Job Summary :

The Clinical Research Coordinator (CRC) is responsible for coordinating and managing clinical trials, ensuring compliance with regulations, and managing data. The CRC works closely with researchers, participants, and regulatory agencies to ensure successful trial execution.

Responsibilities :

  1. Trial Coordination : Coordinate clinical trials, including study start-up, conduct, and close-out.
  2. Regulatory Compliance : Ensure compliance with regulations, including FDA, ICH, and GCP guidelines.
  3. Data Management : Manage data, including data entry, data cleaning, and data analysis.
  4. Communication : Communicate with researchers, participants, and regulatory agencies.
  5. Study Documentation : Maintain accurate and complete study documentation, including informed consent forms, case report forms, and study protocols.
  6. Participant Recruitment : Assist with participant recruitment, including screening, enrollment, and retention.
  7. Study Monitoring : Conduct study monitoring, including site visits, data monitoring, and study close-out.
  8. Quality Assurance : Ensure quality assurance, including monitoring and reporting adverse events, and conducting quality control checks.

Requirements :

  1. Education : Bachelor’s degree in a life science, nursing, or related field.
  2. Experience : 1-2 years of experience in clinical research, preferably as a CRC.
  3. Certification : Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Associate (CCRA) certification preferred.
  4. Knowledge : Knowledge of FDA, ICH, and GCP guidelines, as well as clinical research principles and practices.
  5. Skills : Excellent communication, organizational, and analytical skills.
  6. Software : Proficiency in Microsoft Office, electronic data capture (EDC) systems, and clinical trial management systems (CTMS).
  7. Travel : Ability to travel to study sites, as needed.
 Physical and Mental Demands
  1. Work Environment : Office and clinical research settings.
  2. Physical Demands : Ability to sit, stand, and walk for extended periods.
  3. Mental Demands : Ability to concentrate, analyze data, and make sound judgments.

What We Offer

  1. Competitive Salary : Competitive salary and benefits package.
  2. Opportunities for Growth : Opportunities for professional growth and development.
  3. Collaborative Work Environment : Collaborative work environment with a team of experienced researchers and coordinators.