Johns Hopkins Medicine
Clinical Research Regulatory Coordinator I
Johns Hopkins Medicine, St. Petersburg, Florida, United States, 33739
Job Details
Requisition #: 660197
Location: Johns Hopkins All Children's Hospital, St. Petersburg, FL 33701
Category: Allied Health/Clinical Professional
Schedule: Day Shift
Employment Type: Full Time
YOU BELONG HERE What Awaits You?
Career growth and development
Employee and Dependent Tuition Assistance
Diverse and collaborative working environment
Affordable and comprehensive benefits package
Our competitive Benefit Package is designed to support the well‑being and financial security of our employees. You can explore the details of our benefits offering by visiting the following link Johns Hopkins All Children's Hospital | Your benefits virtually (mybenefitsjhhs.com)
Summary The Clinical Research Regulatory Coordinator I for Study Activation will be responsible for ensuring that accurate and up‑to‑date regulatory files are maintained for all pediatric clinical research studies. This person will serve as a central resource for faculty conducting interventional and non‑interventional clinical and translational research. Working closely with the Study Start Up Manager, Clinical Research Managers and study teams, this person will coordinate the submission of initial Institutional Review Board (IRB) applications for complex clinical research studies. In addition, the coordinator will prepare all regulatory binders prior to the start of each study, containing IRB‑approved initial documents and sections for all required documents. This individual will also work to ensure that all applicable changes in study design and/or conduct, and all continuing reviews, are submitted to the IRB in a timely manner. The incumbent will also update the study team on IRB approval status of submitted study changes and continuing reviews.
This role is grant‑funded and therefore temporary in nature. While the position is expected to continue through the life of the grant, ongoing employment is dependent on continued funding.
Qualifications
Bachelor's degree
2 years of clinical research experience equivalent to healthcare experience with knowledge of regulatory and/or study startup process OR
Associate's degree
6 years of experience in clinical research / equivalent healthcare experience with knowledge of regulatory and/or study startup process
Other qualifications
Computer proficiency in using Microsoft Office including Word, Excel, and Outlook
Ability to communicate effectively, both verbally and in writing; ability to read, write, speak and understand English
Excellent organizational and time management skills
Motivated, organized, personable, willing to learn, responsible, reliable, and efficient
Salary Range Minimum 24.95/hour - Maximum 39.92/hour. Compensation will be commensurate with equity and experience for roles of similar scope and responsibility. In cases where the range is displayed as a $0 amount, salary discussions will occur during candidate screening calls, before any subsequent compensation discussion is held between the candidate and any hiring authority.
We are committed to creating a welcoming and inclusive environment, where we embrace and celebrate our differences, where all employees feel valued, contribute to our mission of serving the community, and engage in equitable healthcare delivery and workforce practices.
Johns Hopkins Health System and its affiliates are drug‑free workplace employers.
Johns Hopkins Health System and its affiliates are an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, mental or physical disability, genetic information, veteran status, or any other status protected by federal, state, or local law.
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Requisition #: 660197
Location: Johns Hopkins All Children's Hospital, St. Petersburg, FL 33701
Category: Allied Health/Clinical Professional
Schedule: Day Shift
Employment Type: Full Time
YOU BELONG HERE What Awaits You?
Career growth and development
Employee and Dependent Tuition Assistance
Diverse and collaborative working environment
Affordable and comprehensive benefits package
Our competitive Benefit Package is designed to support the well‑being and financial security of our employees. You can explore the details of our benefits offering by visiting the following link Johns Hopkins All Children's Hospital | Your benefits virtually (mybenefitsjhhs.com)
Summary The Clinical Research Regulatory Coordinator I for Study Activation will be responsible for ensuring that accurate and up‑to‑date regulatory files are maintained for all pediatric clinical research studies. This person will serve as a central resource for faculty conducting interventional and non‑interventional clinical and translational research. Working closely with the Study Start Up Manager, Clinical Research Managers and study teams, this person will coordinate the submission of initial Institutional Review Board (IRB) applications for complex clinical research studies. In addition, the coordinator will prepare all regulatory binders prior to the start of each study, containing IRB‑approved initial documents and sections for all required documents. This individual will also work to ensure that all applicable changes in study design and/or conduct, and all continuing reviews, are submitted to the IRB in a timely manner. The incumbent will also update the study team on IRB approval status of submitted study changes and continuing reviews.
This role is grant‑funded and therefore temporary in nature. While the position is expected to continue through the life of the grant, ongoing employment is dependent on continued funding.
Qualifications
Bachelor's degree
2 years of clinical research experience equivalent to healthcare experience with knowledge of regulatory and/or study startup process OR
Associate's degree
6 years of experience in clinical research / equivalent healthcare experience with knowledge of regulatory and/or study startup process
Other qualifications
Computer proficiency in using Microsoft Office including Word, Excel, and Outlook
Ability to communicate effectively, both verbally and in writing; ability to read, write, speak and understand English
Excellent organizational and time management skills
Motivated, organized, personable, willing to learn, responsible, reliable, and efficient
Salary Range Minimum 24.95/hour - Maximum 39.92/hour. Compensation will be commensurate with equity and experience for roles of similar scope and responsibility. In cases where the range is displayed as a $0 amount, salary discussions will occur during candidate screening calls, before any subsequent compensation discussion is held between the candidate and any hiring authority.
We are committed to creating a welcoming and inclusive environment, where we embrace and celebrate our differences, where all employees feel valued, contribute to our mission of serving the community, and engage in equitable healthcare delivery and workforce practices.
Johns Hopkins Health System and its affiliates are drug‑free workplace employers.
Johns Hopkins Health System and its affiliates are an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity and expression, age, national origin, mental or physical disability, genetic information, veteran status, or any other status protected by federal, state, or local law.
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