Sr. Clinical Research Coordinator (Health, Behavior and Society)

The Johns Hopkins University

Baltimore (MD)

On-site

USD 41,000 - 72,000

Full time

14 days+

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Job summary

The Johns Hopkins University, School of Public Health, is seeking a Sr. Clinical Research Coordinator to oversee its field site for the Long-Life Family Study.

This role manages day-to-day activities of complex studies, develops SOPs, prepares IRB submissions, and ensures regulatory compliance across sites. The position requires a Bachelor's degree in a related field and at least three years of related experience, with a Master's preferred.

Qualifications

Bachelor's degree in a related field is required.
Three years of related experience is required; additional education may substitute for experience and vice versa.
Master's degree is preferred.

Responsibilities

Oversee day-to-day activities of a complex study or multiple studies.
Assist in budget formulation, communications and data systems.
Develop SOPs and data collection forms from protocols.
Develop consent forms for clinical trials and prepare IRB submissions.
Ensure compliance with protocols, procedures and regulations.
Manage recruitment strategies and participant visits across sites.
Track biospecimen deliveries and data uploads to central repositories.
Attend study meetings and provide status updates; suggest protocol changes.
Conduct literature searches and abstract/index information related to subject matter.
Perform audits and quality control of study data.

Skills

Budget Management

Clinical Research ParticipantRecruit–"

Clinical Study Design

Clinical Trial Management System

Data Management

Data Collection & Reporting

Good Clinical Practices

Interpersonal Skills

Project Management

Regulatory Compliance

Report Writing

IRB/Regulatory Submissions

Education

Bachelor's Degree in a related field

Master's Degree in a related field

Tools

Clinical Trial Management System

Job description

The Department of Health, Behavior and Society at the Johns Hopkins School of Public Health is seeking a Sr. Clinical Research Coordinator to oversee its field site for the Long-Life Family Study. 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 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.

In addition to the duties above

Trains, oversees, and monitors participant recruitment and enrollment efforts including obtaining informed consent.
Oversees scheduling and conduct of participant visits throughout the US. Coordinates travel logistics and bookings for research assistants performing visits outside the local area.
Tracks and monitors biospecimen deliveries and data uploads to central repositories
Tracks and reports on study progress at lab and multisite field operations meetings
Performs office related duties included but not limited to: answering phones, picking up and delivering mail, storing and distributing office supplies, handling faxes, scanning, filing, photocopying, collating materials, maintaining the update of study manuals, etc.

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