Research Program Coordinator Senior

2 days ago

Baltimore, Maryland, United States Johns Hopkins University Full time
Job Title: Sr. Research Program Coordinator

We are seeking a highly skilled and experienced Sr. Research Program Coordinator to join our team at Johns Hopkins University. The successful candidate will be responsible for implementing and completing clinical trials with a high degree of independence in performance of functions.

Key Responsibilities:
  • Work independently while engaging colleagues and supervisors at strategic or key moments.
  • Participate in the development, implementation, testing, and evaluation of manuals, questionnaires, and coding structures for efficient data collection.
  • Collaborate with faculty to develop protocols and oversee study-related activities for multiple studies.
  • Analyze data, organize and complete quality control checks of raw data, and use standard statistical techniques to run standard statistics.
  • Recruit participants, schedule study visits, and complete research procedures on participants.
  • Ensure collection of pertinent data and maintain individual participant's binders from internal and external sources.
  • 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 various sources while ensuring accuracy and timeliness.
  • Complete study case report forms and verify patient eligibility for studies.
  • Obtain research meds from investigative pharmacy and process biological samples.
  • Ship biological samples per IATA packaging requirements and present projects/data at meetings.
  • Work on protocol development of sub-studies, participate in sponsor training sessions, 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.
  • Generate IRB study documents and prepare IRB communications.
  • Monitor and comply with IRB reporting deadlines and complete contracts/arrangements for study activities.
  • Responsible for regulatory and compliance documents for multiple sponsored clinical trials.
  • Independently prepare for and participate in audits of studies/monitoring visits.
Requirements:
  • Bachelor's Degree in a 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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