Clinical Research Coordinator II (Ophthalmology) - #Staff

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 Medicine

Equal 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.