Oversee the administrative and scientific implementation of research protocol for complex, multiple NIH and industry sponsored research studies. As part of study team, collaborate with faculty, develop protocol, develop SOP, and oversee study-related activities for one or more studies. Emphasis on implementation of a protocol(s) in collaboration with PI.
Specific Duties and Responsibilities:
Participate in development, testing and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.
Participate as a member of collaborative group study team in study design, analysis of data, involved in discussions of next steps.
Oversee data collection at single site study or at multiple sites of a multi-centered clinical trial.
Analyze data; organize and quality controls raw data, use standard statistical techniques and/or package programs to run standard statistics.
Responsible for research procedures on study participants including measuring blood pressure, obtaining an ECG, phlebotomy, specimen processing and freezer management.
Ensures collection of pertinent data and maintains individual participant's binders from internal and external sources by maintaining a research chart for each research subject. Collects, enters and compiles clinical data from a variety of sources while ensuring accuracy and timeliness of data.
Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements, obtains outside records when required.
Blood sample processing, including obtaining specimens by phlebotomy with appropriate handling and labeling.
Participate in writing manuscripts, abstracts for medical journals and meetings
Participate in presenting projects/data at medical meetings
Participate in working on protocol development of sub-studies
Conduct training sessions and oversee day-to-day activities of lower level program coordinators and other staff working at other locations within multi-centered clinical trial and locally.
Work with study sponsors on study design and/or determine what group can commit to based on patient population, available resources and cost of providing services.
Participate in developing study budget.
Conduct literature searched to provide background information.
Abstract and index information based on knowledge of subject matter.
Perform self-audits and audits other sites.
Ability to travel between the East Baltimore Campus (Johns Hopkins Hospital) and other Hopkins locations (BVMC, Green Spring Station, etc.)
Duties Prior to Start of Study:
IRB application with consent form
Training of GCRC personnel for study start
Contract/arrangements for study activities (e.g. imaging, ECG, labs) and all fee services
Recruitment in conjunction with study collaborators and study sponsors
Once Study begins:
Scheduling of all patients in GCRC Online for all clinical research activities
Scheduling of all patients for all visits for all activities
Completion of all study forms
Biologic sample processing
With patients for all study activities
Obtaining research meds from research pharmacy for study patients
Dr. Thorsten M. Leucker
Sitting in a normal seated position for extended periods of time.
Reaching by extending hand(s) or arm(s) in any direction.
Finger dexterity to manipulate objects with fingers rather than with whole hand or arm, for example, using a keyboard.
Communication skills using the spoken word.
Ability to see and hear within normal parameters.
Ability to move about workspace.
Bachelor's degree in related discipline.
Three years related experience required.
Additional education can substitute for experience, to the extent permitted by the JHU equivalency formula***.
Master's degree strongly preferred.
Clinical research experience, including IRB application and maintenance process.
Special Knowledge, Skills, and Abilities:
Ability to work in MS Excel, MS Access, and MS Word required.
Attention to detail required, as well as the ability to work independently.
***JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
Classified Title: Sr. Research Program Coordinator Working Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $38,920-$53,520 (commensurate with experience) Employee group: Full Time Schedule: Monday-Friday Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002805-SOM DOM Cardiology 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 email@example.com. For TTY users, call via Maryland Relay or dial 711.
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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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