Hybrid Senior Clinical Research Coordinator - Lead Trials

The Johns Hopkins University; Baltimore (MD); Hybrid; USD 30,000 - 52,000; Full time

Job summary

The Johns Hopkins University in Baltimore is seeking a Sr. Clinical Research Coordinator to oversee day-to-day activities of a single complex study or multiple studies, including in-patient, translational research, and multi-site recruitment.

You will ensure protocol compliance and help set goals and budgets. Responsibilities include developing SOPs and consent forms, preparing IRB submissions, coordinating with sponsors, setting up data systems, auditing, and reporting status to the team.

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 beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

Responsibilities

• Assist PI or more senior staff to ensure feasibility of proposed protocol/study design.
• Develop SOPs and data collection forms from protocol(s).
• Develop consent forms for clinical trials based on protocol(s).
• Prepare materials for submission to IRB.
• Contribute to work with sponsors and assess group capacity, resources, and cost of services.
• Ensure compliance with all protocols, procedures, and regulations.
• Participate in developing the study budget.
• Develop and oversee recruitment strategy for participants for one or more assigned studies.
• Set up a data collection system and ensure validity of data.
• Organize and quality control study data.
• Perform self-audits and/or audit other sites.
• Participate in study meetings and provide status updates; recommend protocol changes based on results.
• Conduct literature searches for background information.
• Abstract and index information based on subject matter knowledge.

Skills

Budget Management

Recruitment (participants)

Study Design

Clinical Trial Mgmt System

Data Management

Data Collection & Reporting

GCP

Interpersonal Skills

Project Management

Regulatory Compliance

Report Writing

Education

Bachelor's Degree in a related field

Master's Degree in a related field

Job description

The Johns Hopkins University in Baltimore is seeking a Sr. Clinical Research Coordinator to oversee day-to-day activities of a single complex study or multiple studies, including in-patient, translational research, and multi-site recruitment.

You will ensure protocol compliance and help set goals and budgets. Responsibilities include developing SOPs and consent forms, preparing IRB submissions, coordinating with sponsors, setting up data systems, auditing, and reporting status to the team.