REGULATORY SPECIALIST II

Moffitt Cancer Center; Oregon; Hybrid; USD 60,000 - 92,000; Full time

Job summary

Moffitt Cancer Center is seeking a regulatory professional to support research regulatory activities through evaluation and completion of protocol documents and standardized reports from activation through closure.

The role focuses on regulatory document completion, submission, proper filing and reporting to achieve compliance with internal policies, external sponsor, state statutes, and federal regulations pertinent to research involving human subjects.

Qualifications

• At least 1 year of regulatory experience with oncology preferred.
• Strong knowledge of IRB/IBC processes and biosafety reviews.
• Excellent documentation and data extraction skills.
• Ability to coordinate with internal/external audits and study teams.

Responsibilities

• Identify the difference between study types to file IRB applications.
• Provide study startup/maintenance support to disease programs.
• Create and update informed consent forms and IRB/IBC applications.
• Review protocol materials to complete regulatory submissions.

Skills

IRB/IBC submissions

Regulatory documentation

Study startup/maintenance

Mentoring regulatory staff

Audit coordination

Education

Master's degree in life sciences

Bachelor's degree in life sciences

Associate's degree in related field

High School Diploma/GED

Job description

SummaryPosition Highlights:

To support research regulatory activities through the critical evaluation and 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 policies, external sponsor, state statutes, and federal regulations pertinent to research involving human subjects.

Responsibilities:

• Identify the difference between compassionate use, emergent use, humanitarian device, biomedical, and social science studies to file the appropriate IRB application.
• Ability to provide seamless coverage (Study Startup and/or Maintenance) to any disease programs, as requested by management.
• Create, maintain and update informed consent forms and IRB/IBC Applications.
• 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 Institutional and respective IRB's terminology.
• Independently process applications for Biosafety Committee review in conjunction with IRB applications.
• Mentoring and Training of new regulatory staff.
• Provides mentoring/training to new regulatory staff as well as other members of the research team(s).
• Act as central contact for regulatory queries, providing documentation and processing requests.
• Serves as the primary liaison for protocol regulatory support and will be in constant communication with internal and external customers; meets with study teams regularly to provide progress updates.
• Collaborates with Research Staff in responding to Internal/External Audits.
• Gather required documentation for internal/external audits collaborating with the research staff and draft regulatory responses.
• Regulatory Files Creation and Maintenance
• Assist in assuring that all study documents, including SOP's and regulatory files are maintained in audit-ready condition.

Credentials and Qualifications:

• High School Diploma/GED required.
• HSD with 4 or more years of clinical research regulatory experience (preferably in oncology).
• Associates or Bachelor's Degree with 2 years of clinical research regulatory experience (preferably in oncology).
• Master's Degree with 1 year of clinical research regulatory experience (preferably in oncology).

Preferred:

• Two (2) years experience in clinical research regulatory experience, including study activation.
• Two (2) years experience in oncology.

Salary Range

Salary Range $60,424.00 - $92,102.40Salary 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.

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

then we have a place for you!

1. Equal Employment OpportunityMoffitt 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 AccommodationFederal 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 .

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