Clinical Research Coordinator (Urology)

The Johns Hopkins University

Baltimore (MD)

On-site

USD 50,574,000 - 88,971,000

Full time

25 hours ago

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Job summary

The Johns Hopkins University in Baltimore seeks a Clinical Research Coordinator (Urology) to manage protocol implementation, assist with regulatory tasks, and coordinate participant recruitment and scheduling. The role involves liaising with investigators, nurses, and participants to ensure compliant, efficient study operations.

Responsibilities include consent, data entry, biospecimen coordination, and IRB submissions, with a focus on quality and regulatory adherence in a fast-paced research

Qualifications

Bachelor's Degree in a related field.
Education substitutions may apply per JHU equivalency formula.

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 researchers and staff in executing protocol-related activities.
Explain study background and rationale to participants.
Recruit participants using various strategies (ads, referrals, community events).
Obtain informed consent and schedule participant activities.
Serve as liaison to participants and coordinate study communications.
Set up data collection systems and enter data.
Assist with study meetings and protocol implementation updates.
Prepare IRB submissions and liaise on administrative matters.
Maintain literature background and knowledge of study protocol and equipment.

Skills

Attention to Detail

Clinical Trial Management System

Data Entry

Data Collection and Reporting

Data Management and Analysis

Interpersonal Skills

Oral and Written Communications

Organizational Skills

Project Coordination

Regulatory Compliance

Education

Bachelor's Degree in a related field

Job description

We are seeking a Clinical Research Coordinator in the department of Urology. 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.
Coordinate sample shipments, including packaging and documentation in compliance with IATA and biosafety regulations.
Support audits, monitoring visits, and quality assurance activities.

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