Sr. Clinical Research Coordinator (Research Administration)

The Johns Hopkins University

Baltimore (MD)

Hybrid

USD 30,000 - 52,000

Full time

5 days ago

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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

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 oversees 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.
Abstract and index information based on knowledge of subject matter.
Other duties as assigned.

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