_Clinical Research Coordinator_
in the department of Urology at Sibley Memorial Hospital.

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 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 meetings. + 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 strategies 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
+ Coordinate the collection, processing, storage, and distribution of biospecimens (e.

g., blood, urine, tissue) in accordance with study protocols. + Maintain accurate specimen tracking and inventory using biorepository databases and laboratory information systems. + Ensure compliance with IRB requirements, HIPAA regulations, and Good Clinical Practice (GCP) guidelines. + Process biospecimens (centrifugation, aliquoting, labeling, freezing) following standardized SOPs. + Monitor specimen quality and integrity, including temperature control, chain of custody, and storage conditions. + Collaborate with investigators, lab personnel, and external partners to fulfill specimen requests and support research initiatives. + Prepare and maintain regulatory documents, including protocols, consent forms, and study logs. + Coordinate sample shipments, including packaging and documentation in compliance with IATA and biosafety regulations.

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 a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.
Preferred Qualifications
+ Related undergraduate or work experience in human subjects' research is preferred.
Technical Skills & Expected Level of Proficiency
+ Attention to Detail
Awareness + Clinical Trial Management System
Awareness + Data Entry
Awareness + Data Collection and Reporting
Awareness + Data Management and Analysis
Awareness + Interpersonal Skills
Awareness + Oral and Written Communications
Awareness + Organizational Skills
Awareness + Project Coordination
Awareness + Regulatory Compliance
Awareness _The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.

Classified Title:

Clinical Research Coordinator Role/Level/Range:

ACRO40/E/03/CD

Starting Salary Range:

$17.20
$30.30 HRLY ($23.75/hour targeted; Commensurate w/exp.)
Employee group:

Full Time Schedule:

M-F; 8am-4:30pm

FLSA Status:

Non-Exempt Location:

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Clinical Research Coordinator (Urology) - #Staff