Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. We are seeking a Clinical Research Coordinator II who will administratively coordinate clinical protocol implementation of a single complex study (e.g., in-patient study, translational research involving clinics and labs, participant accrual at multiple sites, study for which Hopkins is a coordinating center) or multiple studies. Will ensure efficient logistical implementation of study activities and provide administrative support for research-related regulatory issues.
Specific Duties & Responsibilities
* Coordinate all activities of a complex clinical research study or multiple studies 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 strategy for participants for one or more
* assigned studies.
* 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 multiple required activities e.g., laboratory tests, visits,
* procedures, and treatment and resolve any schedule conflicts and ensure timely
* participant tracking.
* Serve as liaison to study participants
* Assist with setup of data collection system(s) 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 preparation of submissions to the Institutional Review Board (IRB)
* Liaison with IRB on administrative matters and facilitate communications with the Pl(s) .
* Track/maintain regulatory documentation and clinical care documentation provided to
* increase regulatory compliance.
* Serve as a resource for clinicians involved in the study regarding protocol requirements.
* Conduct literature searches to provide background information. Abstract, index, and
* analyze information.
* Obtain required samples and collaborate with internal and external entities for studies
* involving procurement and processing of clinical samples
* Obtain and maintain excellent operating knowledge of assigned clinical protocols,
* clinical equipment, and clinical computer systems.
* Oversee budget expenditures for study operations
* Ensure adequate study supplies are ordered and maintained, e.g., shipping, laboratory,
* office, specimen handling, etc.
* May train and/or oversee other non-exempt study staff.
* Other duties as assigned.
Minimum Qualifications
* Bachelor's Degree in related field.
* One year of related experience.
* 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.
Technical Skills & Expected Level of Proficiency
* Budget Management - Developing
* Clinical Research Participant Recruitment - Developing
* Clinical Research Knowledge - Developing
* Clinical Trial Management System - Developing
* Data Collection and Reporting - Developing
* Good Clinical Practices - Developing
* Information Gathering - Developing
* Interpersonal Skills - Developing
* Project Coordination - Developing
* Regulatory Compliance - Developing
The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.
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