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.).

• 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.

• 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