Sr. Clinical Research Coordinator (Neurology)

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

Job summary

The Johns Hopkins University in Baltimore is seeking a Sr. Clinical Research Coordinator to oversee day-to-day activities of multiple complex interventional studies in ALS research. You will support protocol feasibility, data systems, recruitment, and budget planning.

Working with the Principal Investigator and sponsors, you will develop SOPs, consent forms, and regulatory submissions, ensure protocol compliance, and manage data collection and entry in EDC systems across sites.

Qualifications

• Bachelor's Degree in a related field is required.
• At least three years of related experience; additional education may substitute.
• JHU equivalency formula allows substitutions as appropriate.

Responsibilities

• Assist PI or senior staff to determine protocol feasibility.
• Develop SOPs and data collection forms from protocols.
• Prepare consent forms for trials and IRB submissions.
• Contribute to study budgets and recruitment strategies.
• Enter data into Electronic Data Capture systems and ensure data quality.

Skills

Budget Management

Clinical Study Design

Data Management

Regulatory Compliance

Project Management

Report Writing

Education

Bachelor's Degree in related field

Three years of related experience

Master's Degree in related field

Job description

The Department of Neurology is seeking a Sr. Clinical Research Coordinator to assist and support clinical research studies investigating Amyotrophic Lateral Sclerosis. Researchers at Johns Hopkins University conduct clinical trials and clinical studies to discover new ways to prevent and treat diseases and other health problems. The Sr. Clinical Research Coordinator oversees the day-to-day activities of multiple complex interventional studies. 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.
• Other duties as assigned.

In Addition To The Duties Above

• Independently execute all protocol-related activities, including study visit scheduling, pending study drug orders to providers, procuring study drug from Investigational Drug Service, patient assessments, sample processing and shipping and data collection
• Manage all regulatory documentation
• Enter study data into Electronic Data Capture Systems.

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 a 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 & 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.
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: M-F 8:30 am - 5:00 pm
FLSA Status: Exempt
Location: School of Medicine Campus
Department name: SOM Neuro Neuromuscular
Personnel area: School of Medicine