Regulatory Coordinator I - Study Activation

POSITION 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, s/he will prepare all regulatory binders prior to the start of each study, containing IRB-approved initial documents and sections for all required documents all. 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. S/he will also update the study team on IRB approval status of submitted study changes and continuing reviews.

This position is grant-funded for a period of five years and is therefore considered temporary in nature. While the role is expected to continue for the duration of the grant, ongoing employment is contingent upon continued funding

QUALIFICATIONS:

• Either one of the following is required:

• • Bachelor’s degree PLUS

    • 2 years of clinical research experience / equivalent healthcare experience with knowledge of regulatory and/or study startup process OR

• • Associate’s degree PLUS

    • 6 years of experience in clinical research / equivalent healthcare experience with knowledge of regulatory and/or study startup process

• Computer proficiency in using Microsoft Office including Word, Excel, and Outlook

• Must have familiarity with federal regulations for human subject participation in clinical research, including GCP

• 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 25.32/hour - Maximum 40.52/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.

The Hospital reserves the right to modify employee schedules as needed.

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.