We are seeking a Regulatory Specialist IIwho will be responsible for ensuring that all research studies maintain accurate and up-to-date regulatory files. Will serve as a central resource for faculty conducting clinical research. Working closely with the Program Manager and Research Nurse, this position will complete and submit the initial IRB submission. Prior to the start of a study, will ensure all proper regulatory documents have been approved and that all documents, CRF, databases, monitoring/auditing requirements have been completed. Will produce and maintain a regulatory binder prior to the study starting with all required documents and additional sections for future documents. Works closely with the Regulatory Specialist I to ensure all documents are submitted to the IRB in a timely manner.
Specific Duties and Responsibilities
Work closely with the Research Nurse and PI on new studies to ensure timely, accurate submission to the IRB and sponsors.
Assure protocols have complete, consistent language throughout, including proper SAE reporting requirements, coordinating center requirements, etc.
Obtain all required documents for new submissions to the IRB.
Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process.
Complete new study IRB submissions.
Ensures smooth implementation of new trials from conception through study activation.
Work closely with the Protocol compliance team to ensure all documents are ready prior to a study opening.
For IND studies, maintain accurate and up-to-date documents and submissions.
Collect all required documents from sites where SKCCC is the coordinating center prior to study opening.
Attend study start up meeting for studies where SKCCC is the coordinating center.
Produce and maintain a regulatory binder prior to study starting with all required documents.
Work closely with all sponsors to ensure all documents are reviewed, approved and correct prior to a study opening.
Work closely with the Regulator Specialist I to ensure all documents are being collected in a timely manner and all regulatory binders are up-to-date, helping as needed.
Develop standard operating procedures as needed.
Assist CRO in the auditing and monitoring of studies, including external sites.
Requires minimum of three (3) years of experience in academic or industry-based clinical research.
Must have familiarity with NIH, GCP, OHRP, and federal regulations for human subject participation in clinical research.
Excellent verbal and communication skills are required.
*Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
Classified Title: Regulatory Specialist II Role/Level/Range: ACRP/03/MB Starting Salary Range: $40,100-$55,140 Annually (Commensurate with experience) Employee group: Full Time Schedule: M-F 8:30am- 4:30pm Exempt Status: Exempt Location: School of Medicine Campus Department name: SOM Onc Hematologic Malignancies Personnel area: School of Medicine
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines: JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
The successful candidate(s) for this position will be subject to a pre-employment background check.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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