Sr. Research Program Coordinator
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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