Research Program Coordinator Senior
4 weeks ago
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.
- 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.
- 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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