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Sr. Research Program Coordinator

Johns Hopkins University

Job Description

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 

 

 

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