About the position
Johns Hopkins, founded in 1876, is America's first research
university and home to nine world-class academic divisions working
together as one university.
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
The successful candidate(s) for this position will be subject to a
pre-employment background check.
If you are interested in applying for employment with The Johns
Hopkins University and require special assistance or accommodation
during any part of the pre-employment process, please contact the
HR Business Services Office at jhurecruitment@jhu.edu. For TTY
users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which
campus you will work. Your recruiter will advise
accordingly.
During the Influenza ("the flu") season, as a condition of
employment, The Johns Hopkins Institutions require all employees
who provide ongoing services to patients or work in patient care or
clinical care areas to have an annual influenza vaccination or
possess an approved medical or religious exception. Failure to meet
this requirement may result in termination of employment.
The pre-employment physical for positions in clinical areas,
laboratories, working with research subjects, or involving
community contact requires documentation of immune status against
Rubella (German measles), Rubeola (Measles), Mumps, Varicella
(chickenpox), Hepatitis B and documentation of having received the
Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include
documentation of having two (2) MMR vaccines; two (2) Varicella
vaccines; or antibody status to these diseases from laboratory
testing. Blood tests for immunities to these diseases are
ordinarily included in the pre-employment physical exam except for
those employees who provide results of blood tests or immunization
documentation from their own health care providers. Any
vaccinations required for these diseases will be given at no cost
in our Occupational Health office.
Equal Opportunity Employer
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