Regulatory Specialist I

Moffitt Cancer Center; Oregon; Hybrid; USD 33,000 - 50,000; Full time

Job summary

Moffitt Cancer Center is seeking a Regulatory Start-Up Specialist I to support research activities by completing protocol documents and standardized reports from activation through closure, ensuring compliance with IRBs and sponsor requirements.

You will draft informed consent, process IRB submissions, and manage ebinders and OnCore records while collaborating with study teams and sponsors to ensure regulatory readiness.

Qualifications

• High School Diploma/GED required.
• Associate's degree with 2+ years of relevant experience, or HSD with 3+ years of relevant experience; BS/MS may substitute.

Responsibilities

• Review and extract required data from protocol, investigator's brochure, and source documents to complete the application process; draft informed consent with model language and IRB terminology.
• Provide draft consents to the sponsor for approval.
• Process BioSafety and IRB applications and complete OBA requirements as necessary.
• Collaborate with research team/sponsor for regulatory information required for application completion.
• File HIPAA/Consent waivers when applicable through the IRB.
• Submit application documents along with addenda to the IRB.
• Process the 1572 and financial disclosures.
• File electronic copies in ebinders per CTO standards.
• Provide regulatory start-up information to sponsors, including credentialing for staff and certifications.
• Reconcile IRB queries to ensure study approval.
• Provide approval documents to stakeholders.
• Process and submit modifications/amendments to the IRB.
• Process and submit information reports to the IRB.
• Process progress reports with addenda within timelines for study continuation.
• Process final reviews for study termination to ensure compliance.
• Run OnCore reports and process IRB forms.
• File correspondence for future retrieval and upload IRB approvals to ebinders and OnCore.
• Act as liaison between internal and external customers; draft regulatory responses.
• Gather documentation for audits with the research staff.

Skills

Word processing

Database usage

Education

High School Diploma/GED

Associate's degree

BS/MS substitution option

Job description

Working at Moffitt is both a career and a mission: to contribute to the prevention and cure of cancer.

As the only National Cancer Institute-designated Comprehensive Cancer Center based in Florida, Moffitt employs some of the best and brightest minds from around the world. Join a dedicated team of nearly 11,000 who are shaping the future we envision. Moffitt has been recognized as a Best and Brightest Company to Work For in the Nation and is continually named one of the Tampa Bay Times' Top Workplaces.

SummaryPosition Highlights

To support research activities through the completion of protocol specific documents and standardized reports for effective and compliant protocol activity from activation through closure. The primary focus is on regulatory document completion, submission, proper filing and reporting to achieve and maintain compliance with internal policy (Moffitt) IRBs, external sponsor and federal regulations pertinent to research involving human subjects.

Credentials and Qualifications

• High School Diploma/GED required.
• HSD with 3 or more years of relevant experience or Associate's degree with 2 or more years of relevant experience. BS or MS degree may substitute the relevant experience.
• Thorough knowledge of word processing and database usage required.

Responsibilities

• Assist to review and extract all required data from the protocol, investigator's brochure, and any other pertinent source documentation to complete the application process to include drafting the informed consent by combining model consent language with Moffitt/Respective IRB's terminology.
• Provide draft consents to the respective sponsor for approval.
• With either manager or mentor, Reg. Spec I will process BioSafety applications in conjunction with IRB applications and complete OBA requirements as necessary.
• Collaborate with the respective research team/sponsor for scientific/clinical information required for application completion
• File HIPAA/Consent waivers when applicable through the IRB
• Submit application documents along with appropriate addenda to the respective IRB
• Process the 1572 and financial disclosures.
• File all electronic copies in ebinders according to CTO standards
• Provide Regulatory start up information to the respective sponsors to include credentialing for each research staff member as well as Moffitt's certifications.
• Reconcile all IRB queries to ensure study approval.
• Provide approval documents to respective stakeholders.
• Process and submit modifications/amendments to the IRB documenting any study changes.
• Process and submit information reports to the IRB documenting any protocol deviations, exceptions, and/or other information that only requires IRB acceptance rather than approval.
• Process and submit progress reports along with respective addenda within the specified timeframe to ensure study continuation.
• Process final reviews for formal study termination to ensure regulatory compliance.
• Run OnCore reports and research data to process IRB forms.
• Electronically file all correspondence for future retrieval and upload all IRB approvals to ebinders and OnCore accordingly.
• Act as a study liaison between internal and external customers answering queries, providing documentation, processing requests, etc.
• Gather required documentation for internal/external audits collaborating with the research staff and draft regulatory responses.
• Track workload in Excel and file weekly in the CTO drive using approved CTO tracking logs.

Salary Range $23.90 - $36.41

Salary ranges posted for this position represent the expected base pay range for the role. Actual compensation may vary based on location and a variety of job-related factors, including experience, skills, education, and internal equity among Team Members in similar positions.We are committed to maintaining fair and equitable pay practices and regularly review compensation to ensure alignment across our workforce.Moffitt Career Site

If you have the vision, passion, and dedication to contribute to our mission,

then we have a place for you!

1. Equal Employment Opportunity

Moffitt Cancer Center is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, or protected veteran or disabled status. We seek candidates whose skills, and personal and professional experience, have prepared them to contribute to our commitment to diversity and excellence.

2. Reasonable Accommodation

Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Moffitt endeavors to make moffitt.org/careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact one of the Human Resources receptionists by phone at or by email at . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.Read more information about your EEO rights under the law .Transparency in Coverage Rule