Regulatory Coordinator I Study Activation
Job Location:
Pinellas County, FL - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
POSITIONSUMMARY:
TheClinicalResearchRegulatoryCoordinator I for Study Activationwillberesponsibleforensuringthataccurateand up-to-date regulatory files aremaintainedfor allpediatric clinicalresearchstudies. This person will serve as a central resource for faculty conducting interventional and non-interventional clinical and translational closely with the Study Start Up Manager Clinical ResearchManagersand study teams this person will coordinate the submission ofinitialInstitutional Review Board (IRB) applications for complex clinical research addition s/he will prepare all regulatory binderspriortothestartofeachstudycontainingIRB-approvedinitialdocuments and sectionsforallrequireddocumentsall. Thisindividual willalso worktoensurethat all applicablechanges in studydesign and/or conduct and allcontinuingreviewsaresubmittedtotheIRBinatimelymanner.S/hewill also updatethestudyteamonIRBapproval status ofsubmittedstudy 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:
Eitheroneofthefollowingisrequired:
Bachelorsdegree PLUS
2 years of clinical research experience / equivalent healthcare experience with knowledge of regulatory and/or study startup process OR
AssociatesdegreePLUS
6 years of experience in clinical research / equivalent healthcare experience with knowledge of regulatory and/or study startup process
ComputerproficiencyinusingMicrosoftOfficeincludingWordExcelandOutlook
MusthavefamiliaritywithfederalregulationsforhumansubjectparticipationinclinicalresearchincludingGCP
Abilitytocommunicateeffectivelybothverballyandinwriting;abilitytoreadwritespeakandunderstandEnglish
Excellentorganizationalandtimemanagementskills
Motivatedorganizedpersonablewillingtolearnresponsiblereliableandefficient
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 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.
Johns Hopkins Health System and its affiliates are drug-free workplace employers.
Required Experience:
IC
About Company
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