Sr. Clinical Research Coordinator

Sr. Clinical Research Coordinator

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. Clinical Research 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.

Additional duties & responsibilities:

• Collaborate with the Alzheimer's Anti amyloid Treatment (AAT) program director to track and manage program operations.
• Schedule and facilitate meetings, including agendas and minutes (e.g., AAT program meetings, seminars)
• Serve as the central coordination point between patients, memory clinic, radiology, and infusion services
• Monitor and support patient satisfaction throughout treatment.
• Learn and assist with phlebotomy (preferred but not mandatory)
• Create PowerPoint presentations to communicate clinical and program updates.
• Track and compile publications, presentations, and grants for quarterly reporting.

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

Preferred Qualifications:

• Master's Degree in a related field.

Technical Skills and Expected Level of Proficiency:

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

The core technical skills listed are most essential; additional technical skills may be required based on specific division or department needs.