Clinical Research Coordinator II (Ophthalmology)

The Johns Hopkins University

Baltimore (MD)

On-site

USD 28,000 - 50,000

Full time

22 hours ago

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Job summary

The Johns Hopkins University in Baltimore, MD, seeks a Clinical Research Coordinator II to administratively coordinate the implementation of a complex clinical protocol or multiple studies. You will support study teams, recruit participants, obtain consent, and ensure regulatory compliance.

Responsibilities include coordinating start-up activities, data collection, IRB submissions, budget oversight, and collaboration with nurses, investigators, and external partners.

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.

Responsibilities

Coordinate activities of a complex clinical study to ensure adherence to protocol.
Assist with start-up meetings and the consenting process for participants.
Explain the study background and rationale to potential and current participants.
Develop recruitment strategies and conduct participant recruitment for one or more studies.
Prepare IRB submissions and maintain regulatory documentation.
Enter and organize data; assist with data collection systems and study meetings.
Oversee study budgets and ensure adequate supplies are ordered and maintained.
Train and oversee other non-exempt study staff as needed.

Skills

Budget Management

Clinical Research Knowledge

Clinical Trial Management System

Data Collection and Reporting

Good Clinical Practices

Interpersonal Skills

Project Coordination

Regulatory Compliance

Information Gathering

Education

Bachelor's Degree in related field

Job description

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