Sr. Clinical Research Coordinator (Research Administration)

About the role

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 Senior Clinical Research Coordinator to oversee the day-to-day activities of a single complex study or multiple clinical research studies.

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.

Requirements

• Bachelor's Degree in a related field.
• Three years of related experience.

Qualifications

• Master's Degree in a related field preferred.

Skills

• Budget Management
• Participant Recruitment
• Clinical Research Participant Recruitment
• Clinical Study Design
• Clinical Trial Management System
• Data Management and Analysis
• Data Collection and Reporting
• Good Clinical Practices
• Interpersonal Skills
• Project Management
• Regulatory Compliance
• Report Writing