Sr. Clinical Research Coordinator (Oncology)

The Johns Hopkins University; Baltimore (MD); Hybrid; USD 42,000 - 74,000; Full time

Job summary

The Johns Hopkins University is seeking a Sr. Clinical Research Coordinator to oversee day-to-day activities of multiple clinical studies at two sites, including inpatient and translational research components.

You will assist in feasibility assessments, protocol development, and sponsor communications, ensuring compliance and robust data systems. Responsibilities include developing SOPs, consent forms, and IRB submissions, maintaining regulatory files, budgeting input, and leading participant

Qualifications

• Bachelor's Degree in a related field.
• Three years of related experience.
• Experience with IRB and regulatory compliance is a plus.

Responsibilities

• Oversee day-to-day activities of multiple clinical studies across two sites.
• Develop SOPs and data collection forms from protocols.
• Create consent forms for clinical trials based on protocols.
• Prepare material for IRB submissions and maintain regulatory files.
• Collaborate with sponsors to assess resources and costs.
• Ensure compliance with all protocols and regulations.
• Assist in budget development and recruitment strategy for participants.
• Set up data collection systems and manage study data.
• Conduct data quality checks and site audits.
• Provide status updates and suggest protocol improvements.

Skills

Clinical research coordination

IRB knowledge

Education

Bachelor's Degree

Job description

Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. In Upper Aerodigestive Cancer Program, we are seeking a Sr. Clinical Research Coordinator who will oversee the day-to-day activities of multiple clinical research studies at two sites (e.g., in-patient study, translational research involving clinics and labs, participant accrual at multiple sites) 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.
• Maintain regulatory files.
• 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.
• Data management of multiple studies.
• 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.
• 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 permitted by the JHU equivalency formula.

Classified Title: Sr. Clinical Research Coordinator

Role/Level/Range: ACRP/03/MB

Starting Salary Range: $42,330 - $74,110 Annually ($58,220 targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: Mon - Fri/8a - 4:30p

FLSA Status: Exempt

Location: Hybrid/School of Medicine Campus

Department name: SOM Onc Upper Aerodigestive Cancer

Personnel area: School of Medicine