Senior Clinical Research Coordinator

2 weeks ago

Sugar Land, United States World Research Link Full time
Job DescriptionJob Description

Job Summary: The Senior Clinical Research Coordinator (CRC) is responsible for overseeing and managing clinical trials and research studies. This role involves coordinating the planning, implementation, and monitoring of research projects to ensure compliance with regulatory standards and protocol adherence. The Senior CRC will work closely with investigators, study sponsors, and regulatory agencies to facilitate the successful execution of clinical research.

Key Responsibilities:

Study Coordination:

  • Manage day-to-day operations of clinical trials, including patient recruitment, informed consent, and screening processes.
  • Develop study protocols, case report forms, and other study-related documents in collaboration with the research team.

Regulatory Compliance:

  • Ensure all studies comply with Good Clinical Practice (GCP), institutional policies, and regulatory requirements.
  • Prepare and submit regulatory documents to Institutional Review Boards (IRBs) and other regulatory bodies.

Data Management:

  • Oversee data collection, entry, and validation processes to ensure accuracy and integrity of study data.
  • Monitor and address data discrepancies and implement corrective action as needed.

Team Leadership:

  • Supervise and train junior staff and research coordinators in clinical trial processes and best practices.
  • Foster a collaborative and productive work environment within the research team.

Communication:

  • Serve as the primary point of contact for study sponsors, investigators, and regulatory agencies.
  • Prepare and present study progress updates to stakeholders and participate in project meetings.

Budget and Resource Management:

  • Assist in the development of study budgets and manage study-related expenditures.
  • Coordinate with vendors and suppliers for study materials and resources.

Quality Assurance:

  • Participate in site audits and inspections, ensuring compliance with all aspects of the study.
  • Implement and maintain proper documentation practices to support audit readiness.

Qualifications:

  • Minimum of 2 years of experience in clinical research.
  • Strong knowledge of clinical research protocols, GCP, and regulatory requirements.
  • Excellent organizational, communication, and interpersonal skills.
  • Ability to work independently and manage multiple tasks in a fast-paced environment.
  • Proficiency in clinical trial management software and electronic data capture systems.

Preferred Qualifications:

  • Bachelor’s degree in life sciences, nursing, or a related field (Master’s degree preferred).
  • Experience in oncology, psychiatry, neurology, pediatrics, cardiology

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