Clinical Research Program Coordinator Senior

2 days ago

Baltimore, Maryland, United States Johns Hopkins University Full time

We are seeking a highly skilled and experienced Sr. Clinical Research Program Coordinator to join our team. The successful candidate will be responsible for implementing and completing Cardiology/Electrophysiology clinical trials with a high degree of independence. The Sr. Clinical Research Program Coordinator will maintain knowledge of study protocols and assist in the daily operations of the recruitment under the direction of the Principal Investigator and Co-Investigators.

The ideal candidate will have a strong background in clinical research, excellent organizational skills, and the ability to work well in a team environment. They will be responsible for coordinating patient-related tasks, managing data, and ensuring compliance with regulatory requirements.

The Sr. Clinical Research Program Coordinator will also be responsible for developing and maintaining records of research activities, preparing periodic and ad-hoc reports, and assisting with IRB submissions and applications. They will work closely with the research team to ensure the smooth and efficient day-to-day operation of research and data collection activities.

Key Responsibilities:

  • Recruit, instruct, and coordinate research subjects to specific study objectives and work scope.
  • Schedule study follow-up visits and research-related tests to ensure that subjects are seen in the study window timeframe to minimize protocol deviations.
  • Implement and maintain data collection and analysis systems in support of research protocol, including management of data, paper files, subject binders, and electronic databases.
  • Ensure the smooth and efficient day-to-day operation of research and data collection activities in compliance with The Health Insurance Portability and Accountability Act (HIPAA) and other relevant patient privacy statutes.
  • Act as the primary administrative point of contact for internal research staff.
  • Process all sponsor requests for study revisions and required reporting.
  • Coordinate the day-to-day activities in the carrying out of research protocol, may perform aspects of research protocol in accordance with specified program objectives.
  • Develop and maintain records of research activities and prepares periodic and ad-hoc reports as required by investigators and/or regulatory bodies.
  • Assist with reporting protocol deviations and adverse events in a timely manner.
  • Assist with maintaining study inventory according to regulatory standards.
  • Work with Compliance Committees and Institutional Review Boards.
  • Assist with IRB submissions/applications. Prepares and maintains IRB and other regulatory documentation for multiple projects.
  • Maintain compliance with Good Clinical Practice Guidelines, ICH Guidelines, IRB requirements, and Federal Regulations pertaining to research.
  • Perform miscellaneous job-related duties as assigned.

Requirements:

  • Bachelor's Degree in a related discipline.
  • Three years of related experience.
  • Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications:

  • Knowledge of medical terminology highly desired.

Classification: Sr. Research Program Coordinator

Job Title: Sr. Clinical Research Program Coordinator

Department: SOM DOM Cardiology

Location: Hybrid/School of Medicine Campus

Personnel Area: School of Medicine

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