Job Description

The Behavioral Pharmacology Research Unit is seeking a Clinical Research Coordinator who reports to the Sr. Clinical Research Manager. Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Clinical Research Coordinator administratively coordinates clinical protocol implementation, typically for a single study. Will ensure the efficient logistical implementation of the study activities and provide administrative support for research-related regulatory issues.

Specific Duties & Responsibilities

• Coordinate all activities of a clinical research study to ensure adherence to protocol and validity of findings.
• Participate in clinical study start-up meeting.
• Assist research nurses, study coordinators, principal investigators, and other study personnel in executing protocol-related activities.
• Explain the study background and rationale for the research to potential and current participants.
• Contribute to the development of recruitment strategy for participants for assigned study.
• Implement a variety of techniques for recruitment as appropriate, e.g., print and web-based advertisements, contact referring physicians, participate in community events, etc.
• Independently conduct the consenting process or ensure consent is obtained on appropriate participants.
• Schedule participants for required activities and provide any special instructions prior to upcoming tests/exams.
• Serve as liaison to study participants.
• Assist with setup of the data collection system and enter and organize data.
• Assist in coordinating study meetings.
• Participate in study meetings and provide updates on protocol implementation status and make recommendations on operational issues.
• Assist with the preparation of submissions to the Institutional Review Board (IRB).
• Liaison with IRB on administrative matters and facilitate communications with the PI.
• Conduct literature searches to provide background information.
• Obtain and maintain excellent operating knowledge of assigned clinical protocol, clinical equipment, and clinical computer systems.
• Oversee budget expenditures for study operations.
• Other duties as assigned.

In addition to the duties described above

• Prepare study materials for bi-annual quality assurance checks.
• Assist with the preparation of study reports, publications, and presentations.
• Promptly relay staff issues to the RPS (within 48 hours) and assist with issue resolution.
• Provide backup in the event of staff absences, scheduling conflicts, and other program needs. Become conversant with protocols other than primary assignment and provide training or back-up for these protocols.
• Contribute to BPRU initiatives outside of study related tasks. Such responsibilities may include mentoring new staff, assisting with events, leading new program initiatives, and performing document and data checks.

Minimum Qualifications

• Bachelor's Degree in a related field.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond high school diploma/graduation equivalent to the extent permitted by the JHU equivalency formula.

Technical Skills and Expected Level of Proficiency

• Budget Management - Developing
• Clinical Research Participant Recruitment - Developing
• Clinical Study Design - Developing
• Clinical Trial Management System - Developing
• Data Management and Analysis - Developing
• Data Collection and Reporting - Developing
• Good Clinical Practices - Developing
• Interpersonal Skills - Developing
• Project Management - Developing
• Regulatory Compliance - Developing
• Report Writing - Developing

Preferred Qualifications

• Master's Degree in a related field.

Classified Title: Clinical Research Coordinator
Role/Level/Range: ACRO37.5/03/CD
Starting Salary Range: $17.20 - $30.30 HRLY ($41,500 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Monday thru Friday / 40
FLSA Status: Non-Exempt
Location: Johns Hopkins Bayview
Department name: SOM Psy Bay Behavioral Pharm Rserch Unit
Personnel area: School of Medicine

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