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.

_

Classified Title:

Clinical Research Coordinator II Role/Level/Range:

ACRO40/E/03/CE

Starting Salary Range:

$20.25

• $36.

25 HRLY ($65,364 targeted; Commensurate w/exp.) Employee group:

Full Time Schedule:

Monday-Friday, 8:30 am

• 5:00 pm

FLSA Status:

Non-Exempt Location:

School of Medicine Campus Department name: SOM Oph Retina Service Personnel area: School of MedicineEqual Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.