impact the conduct of the research. Assists in goal setting and creating implementation plans. Contributes to budget formulation, communications, and data systems.
Specific Duties & Responsibilities
- Assist Principal Investigator or more senior research staff to
ensure operational feasibility of proposed protocol/study
design.
- Develop standard operating procedures and data collection forms
from protocol(s).
- Develop consent form(s) for clinical trials based on
protocol(s).
- Prepare materials for submission to IRB.
- Maintain regulatory files.
- Contribute to work with commercial and/or government agency
sponsors and recommend which group can commit to considering
patient population, available resources, and cost of providing
services.
- Ensure compliance with all protocols, procedures, and
applicable regulations.
- Participate in developing the study budget.
- Develop and oversee the implementation of recruitment strategy
for participants for one or more assigned studies.
- Set up a data collection system and ensure the validity of
study data.
- Data management of multiple studies.
- Organize and quality control study data.
- Perform self-audits and/or audit other sites.
- Participate in study meetings and provide status updates and
recommend changes to protocol operations based on results and
goals.
- Conduct literature searches to provide background
information.
- Abstract and index information based on knowledge of subject
matter.
- Other duties as assigned.
Minimum Qualifications
- Bachelor's Degree in a related field.
- Three years of related experience.
- Additional education may substitute for required experience and
additional related experience may substitute for required education
permitted by the JHU equivalency formula beyond a high school
diploma/graduation equivalent, to the extent permitted by the JHU
equivalency formula.
Classified Title: Sr. Clinical Research Coordinator
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $42,330 - $74,110 Annually ($58,220
targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Mon - Fri/8a - 4:30p
FLSA Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM Onc Upper Aerodigestive Cancer
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.
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