We are seeking a Sr. Research Program Coordinator who will oversee the administrative and scientific implementation of research protocol for complex, multiple 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.
Specific Duties & Responsibilities
Participate in development, implementation, 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 for clinical trials and investigator-initiated research.
Oversee data collection at single site study.
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 presenting projects/data at medical meetings
Participate in working on protocol development of sub-studies
Participate in sponsor training sessions and train other staff ensure compliance per sponsor guidelines.
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 budgets.
Responsible for regulatory and compliance documents for multiple industry sponsored clinical trials
Abstract and index information based on knowledge of subject matter.
Perform self-audits and site audits
Ability to travel between the East Baltimore Campus (Johns Hopkins Hospital) and other Hopkins locations (Bayview Medical Center, Green Spring Station, etc.)
Duties Prior to Start of Study
IRB application with consent form.
iLab applications and CRU setup.
Training site personnel for study start.
Contract/arrangements for study activities (e.g. Echo, CPET, MRI, labs) and all fee services.
Recruitment in conjunction with study collaborators and study sponsors.
Once Study Begins
Scheduling of all patients in iLab for all clinical research activities.
Scheduling of all patients for all visits for all activities.
Completion of all study forms.
Biologic sample mailing.
Work with patients for all study activities.
Obtaining research meds from research pharmacy for study patients.
Bachelor's Degree in related discipline.
Three years related experience.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Clinical research experience, including IRB application and maintenance process.
Master's Degree strongly preferred.
Classified Title: Sr. Research Program Coordinator Role/Level/Range: ACRP/03/MB Starting Salary Range: $40,100-$55,140-$70,180 Annually (Commensurate with experience) Employee group: Full Time Schedule: M-F 8:00am - 4:30pm Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM DOM Cardiology Personnel area: School of Medicine
Total Rewards The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. 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.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
The successful candidate(s) for this position will be subject to a pre-employment background check. Johns Hopkins is committed to hiring individuals with a justice-involved background, consistent with applicable policies and current practice. A prior criminal history does not automatically preclude candidates from employment at Johns Hopkins University. In accordance with applicable law, the university will review, on an individual basis, the date of a candidate's conviction, the nature of the conviction and how the conviction relates to an essential job-related qualification or function.
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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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