Sr. Clinical Research Coordinator (Neurology)

Johns Hopkins University

Maryland

On-site

USD 42,000 - 74,000

Full time

14 days+

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Job summary

Myana seeks a Sr. Clinical Research Coordinator to oversee day-to-day operations of complex interventional ALS studies and support budget formulation and data systems.

You will work with Johns Hopkins University investigators to implement protocols, consent forms, and regulatory documents. You will independently manage study visits, data capture, regulatory files, and recruitment strategies while ensuring compliance with GCP and study timelines.

Qualifications

Bachelor's Degree in a related field is required.
Three years of related experience are required.
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.
Master's Degree in a related field is preferred.

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.
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.

Skills

Budget Management

Clinical Research Recruitment

Clinical Study Design

Clinical Trial Management System

Data Management

Data Collection and Reporting

Good Clinical Practices

Interpersonal Skills

Project Management

Regulatory Compliance

Report Writing

Education

Bachelor's Degree in a related field

Master's Degree in a related field

Tools

Electronic Data Capture (EDC) Systems

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