Clinical Research Coordinator

3 days ago

Seattle, Washington, United States Crox Consulting Inc Full time
Job Summary:

We are seeking a highly skilled and detail-oriented Clinical Research Coordinator to join our team at Crox Consulting Inc. The successful candidate will be responsible for overseeing and managing clinical trials, ensuring compliance with regulatory requirements, and maintaining accurate and organized records.

Key Responsibilities:

  • Coordinate and manage clinical trials from initiation to completion, ensuring seamless execution and timely delivery.
  • Ensure compliance with FDA, GCP, and ICH guidelines, maintaining a strong understanding of regulatory requirements and industry standards.
  • Recruit, screen, and enroll study participants, utilizing effective communication and interpersonal skills to build strong relationships.
  • Obtain informed consent from study participants, ensuring transparency and adherence to ethical standards.
  • Monitor participant progress and maintain accurate records of study data, utilizing data management and analysis software to optimize results.
  • Prepare and submit regulatory documents to the Institutional Review Board (IRB), ensuring timely and accurate submissions.
  • Conduct site initiation, routine monitoring, and close-out visits, maintaining a strong understanding of study protocols and procedures.
  • Develop and implement study protocols and procedures, collaborating with cross-functional teams to ensure effective execution.
  • Manage study budgets and resolve billing issues, utilizing strong financial management skills to optimize resources.
  • Train and supervise research staff, ensuring adherence to study protocols and procedures.
  • Communicate effectively with study sponsors, investigators, and regulatory agencies, maintaining strong relationships and ensuring timely communication.
  • Perform data collection, entry, and analysis using relevant software, utilizing strong analytical skills to optimize results.

Qualifications:

  • Bachelor's degree in a related field (e.g., Public Health, Nursing, Biology).
  • Minimum of 2 years of experience in clinical research coordination.
  • Strong knowledge of FDA, GCP, and ICH guidelines.
  • Excellent organizational and time-management skills.
  • Proficiency in data management and analysis software (e.g., SPSS, SAS, R).
  • Strong interpersonal and communication skills.
  • Ability to work independently and as part of a team.
  • Certification as a Clinical Research Coordinator (CCRC) or Clinical Research Professional (CCRP) is preferred.

Benefits:

  • Competitive salary and benefits package.
  • Opportunities for professional development and continuing education.
  • Collaborative and supportive work environment.

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