Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. We are seeking a Sr. Research Program Coordinator who will oversee the day-to-day activities of a single complex study (e.g., in-patient study, translational research involving clinics and labs, participant accrual at multiple sites, study for which Hopkins is a coordinating center) or multiple clinical research studies and makes independent decisions that impact the conduct of the research. Assists in goal setting and creating implementation plans. Contributes to budget formulation, communications, and data systems.

Specific Duties & Responsibilities

• Assist Principal Investigator or more senior research staff to ensure operational feasibility of proposed protocol/study design.
• Develop standard operating procedures and data collection forms from protocol(s).
• Develop consent form(s) for clinical trials based on protocol(s).
• Prepare materials for submission to IRB.
• Contribute to work with commercial and/or government agency sponsors and recommend which group can commit to considering patient population, available resources, and cost of providing services.
• Ensure compliance with all protocols, procedures, and applicable regulations.
• Participate in developing the study budget.
• Develop and oversee the implementation of recruitment strategy for participants for one or more assigned studies.
• Set up a data collection system and ensure the validity of study data.
• Organize and quality control study data
• Perform self-audits and/or audit other sites.
• Participate in study meetings and provide status updates and recommend changes to protocol operations based on results and goals.
• Conduct literature searches to provide background information.
• Abstract and index information based on knowledge of subject matter.
• Ensures smooth implementation of new trials from IRB approval through study activation including collection of regulatory documentation for Sponsor and Investigator initiated studies.
• Working closely with Sponsors and Investigators, will submit and track each assigned protocol amendment through the IRB/subcommittee approval process, revise RedCap database as applicable and update all manuals and documents pertaining to the amendment.
• Assist in ongoing reviews of all regulatory binders to ensure that documents are up to date and meet all Sponsor, protocol and Cancer Center requirements.
• Will work with lead study coordinators, research nurses and investigators to address issues identified in the review of regulatory binders.
• Maintain central regulatory files for all staff including licenses, master delegation logs, CV's and IRB training documents for Good Clinical Practice.
• Other duties as assigned.

Minimum Qualifications

• Bachelor's Degree in a related field.
• Three years of related experience.
• Additional education may substitute for required experience and additional related experience may substitute for required education permitted by the JHU equivalency formula. Beyond a high school diploma/graduation equivalent, to the extent.

Classified Title: Sr. Research Project Coordinator
Job Posting Title (Working Title): Sr Research Program Coordinator (Oncology)
Role/Level/Range: ACRP/03/MB
Starting Salary Range: $41,300 - $72,300 Annually ($54,000- 57,000 targeted; Commensurate w/exp.)
Employee group: Full Time
Schedule: Mon - Fri / 8:30a - 5p
FLSA Status: Exempt
Location: Hybrid/School of Medicine Campus
Department name: SOM Onc Urologic Oncology
Personnel area: School of Medicine