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Job Req ID:  115781

Sr. Research Program Coordinator

We are seeking a Sr. Research Program Coordinator who will be responsible for implementing and completing Heart Failure with Preserved Ejection Fraction (HFpEF) clinical trials with a high degree of independence in performance of functions. As part of the study team, will collaborate with faculty, develop protocols, develop SOPs, and oversee study-related activities for multiple studies. 


Specific Duties & Responsibilities

  • Work independently while engaging colleagues and supervisors at strategic or key moments.
  • Work independently and under the direction of the supervisor to ensure successful completion of clinical research studies.
  • Participate in the development, implementation, testing, and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data.
  • Participate as a member of a collaborative group in study design and analysis of data.
  • Adhere to all protocol requirements to ensure validity of clinical research data.
  • Participate in and oversee data collection.
  • Analyze data - organize and complete quality control checks of raw data, use standard statistical techniques and/or package programs to run standard statistics.
  • Recruit participants in conjunction with study collaborators and study sponsors, including interacting with clinicians and other gatekeepers to access the population.
  • Schedule participants for all activities for study visits.
  • Complete study visits, including completion of research procedures on participants, for example,
    • Anthropometric measurements
    • Blood pressure
    • EKG
    • Specimen collection, including phlebotomy
  • Ensure collection of pertinent data and maintain individual participant’s binders from internal and external sources by maintaining a research chart for each research subject.
  • Monitor and maintain supply of research supplies and order as needed.
  • Evaluate and prepare adverse event reports and other regulatory documents.
  • Collect, enter, and compile data from a variety of sources (including EHR) while ensuring accuracy and timeliness.
  • Complete study case report forms.
  • Verify patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements, obtain outside records when required.
  • Obtain research meds from investigative pharmacy.
  • Process biological samples, including appropriate handling and labeling.
  • Ship biological samples per IATA packaging requirements.
  • Present projects/data at meetings.
  • Work on protocol development of sub-studies.
  • Participate in sponsor training sessions (virtual and in person) and train other staff to ensure compliance per sponsor guidelines.
  • Coordinate and participate in the interviewing and training of new research staff on study protocols, procedures, and reporting.
  • Work with study sponsors on study design and/or determine what the group can commit to based on patient population, available resources, and cost of providing services.
  • Participate in developing study budgets.
  • Generate IRB study documents (including protocols and consent forms) and prepare IRB communications.
  • Monitor and comply with IRB reporting deadlines.
  • Complete contracts/arrangements for study activities (e.g. Echo, CPET, MRI, labs) for fee services.
  • Responsible for regulatory and compliance documents for multiple sponsored clinical trials.
  • Independently prepare for and participate in audits of studies/monitoring visits.
  • Participate in research group meetings.
  • Travel between the East Baltimore Campus (Johns Hopkins Hospital) and other Hopkins locations (JHBMC, Green Spring Station, etc.).


Minimum Qualifications
  • 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.


Preferred Qualifications
  • Master’s Degree strongly preferred.
  • Clinical research experience, including development of compliance materials, work on IRB applications, and conducting multiple studies according to ICH-GCP guidelines.

 

 

Classified Title: Sr. Research Program Coordinator 
Role/Level/Range: ACRP/03/MB  
Starting Salary Range: $41,300 - $72,300 Annually ($56,250 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F 8:30am-5:00pm 
Exempt Status: Exempt 
Location: School of Medicine Campus 
Department name: ​​​​​​​SOM DOM Cardiology  
Personnel area: School of Medicine 

 

 

Total Rewards
The referenced base salary range represents the low and high end of Johns Hopkins University’s salary range for this position. Not all candidates will be eligible for the upper end of the salary range. Exact salary will ultimately depend on multiple factors, which may include the successful candidate's geographic location, skills, work experience, market conditions, education/training and other qualifications. 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/.

Education and Experience Equivalency
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 Completing Studies
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.

Background Checks
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.

Diversity and Inclusion
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.

Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

EEO is the Law
https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

Accommodation Information
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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit https://accessibility.jhu.edu/.

Vaccine Requirements
Johns Hopkins University strongly encourages, but no longer requires, at least one dose of the COVID-19 vaccine. The COVID-19 vaccine does not apply to positions located in the State of Florida. We still require all faculty, staff, and students to receive the seasonal flu vaccine. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. This change does not apply to the School of Medicine (SOM). SOM hires must be fully vaccinated with an FDA COVID-19 vaccination and provide proof of vaccination status. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.

The following additional provisions may apply, depending upon campus. Your recruiter will advise accordingly.
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.
School of Medicine - East Baltimore Campus

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