University of Pennsylvania
Clinical Research Regulatory Specialist B (Abramson Cancer Center)
University of Pennsylvania, Medicine Lake, Minnesota, United States
Overview
Clinical Research Regulatory Specialist B (Abramson Cancer Center) at the University of Pennsylvania. Contingent upon funding. The Abramson Cancer Center One Cancer Clinical Research (OCCR) develops and implements cancer clinical trials that offer cutting-edge oncology treatments. Job Responsibilities
Coordinate the regulatory aspects of Phase I–V clinical trials. Prepare and process regulatory documentation through the IRB, CTSRMC, FDA and applicable regulatory review committees, including new submissions, continuing reviews, amendments, adverse events, and reportable events. Organize and maintain regulatory affairs documentation/files required by sponsors and regulatory bodies. Resolve regulatory and data queries; participate in initiation, monitoring, audit and close-out visits. Participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings. Facilitate development and submission of FDA IND applications and annual reports; develop/maintain study-specific case report forms and source document tools. Provide direct regulatory/compliance guidance and facilitate investigator-initiated trials and investigator-initiated multi-site trials. Perform additional duties related to regulatory affairs as assigned. Qualifications
Bachelor’s degree (life science or human subject protection field preferred) and 3–5 years of research experience or equivalent combination; at least 1 year regulatory experience preferred. Experience with high-risk biomedical research and/or oncology regulatory research preferred. Knowledge of IRB and human research protection regulations, including ICH GCP guidelines. Strong problem-solving, communication, writing, organizational, and time management skills; able to multi-task; able to work independently or as part of a team; attention to detail; willingness to learn and grow. General computing proficiency; intermediate/advanced skills in Microsoft Office; familiarity with collaboration tools (Slack, Microsoft Teams, Zoom, WebEx, etc.). Knowledge/experience with web-based e-regulatory document management systems (eFlorence, Veeva) is a plus. Job Location
Philadelphia, Pennsylvania Department / School
Perelman School of Medicine Pay Range
$62,000.00 - $70,119.00 Annual Salary offers are based on the candidate’s qualifications, experience, skills, and education as they relate to the requirements of the position, and aligned with salary ranges based on external market data. Internal organization and peer data at Penn are also considered. Equal Opportunity Statement
The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law. Special Requirements
Background checks may be required after a conditional job offer. Consideration of the background check will be tailored to the requirements of the job. University Benefits
Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family. Flexible spending accounts are available for eligible health care and dependent care expenses with pre-tax dollars.
Tuition : Tuition assistance for employee, spouse, and dependent children; dependent children may also be eligible for tuition assistance at other institutions.
Retirement : Generous retirement plans (Basic, Matching, Supplemental) with a range of investment options through TIAA and Vanguard; options for pre-tax or Roth contributions.
Time Away from Work : Substantial paid time off to accommodate personal needs, vacations, illness, or family obligations.
Long-Term Care Insurance : Optional long-term care insurance in partnership with Genworth Financial; underwriting rules apply for eligible family members; newly hired employees may apply without health evidence.
Wellness and Work-life Resources : Programs and resources to support health, family, and work-life balance.
Professional and Personal Development : Resources to advance professional and personal growth.
University Resources : Access to libraries, athletic facilities, cultural activities, and on-site events; many activities may be accessed by you and your family.
Discounts and Special Services : Discounts on arts, entertainment, transportation, mortgages, cellular plans, movie tickets, and theme park admissions.
Flexible Work Hours : Flexible work options to balance work and personal commitments.
Penn Home Ownership Services : Forgivable loan for eligible employees for home purchase or improvements.
Adoption Assistance : Reimbursement for eligible adoption-related expenses up to two adoptions per household.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
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Clinical Research Regulatory Specialist B (Abramson Cancer Center) at the University of Pennsylvania. Contingent upon funding. The Abramson Cancer Center One Cancer Clinical Research (OCCR) develops and implements cancer clinical trials that offer cutting-edge oncology treatments. Job Responsibilities
Coordinate the regulatory aspects of Phase I–V clinical trials. Prepare and process regulatory documentation through the IRB, CTSRMC, FDA and applicable regulatory review committees, including new submissions, continuing reviews, amendments, adverse events, and reportable events. Organize and maintain regulatory affairs documentation/files required by sponsors and regulatory bodies. Resolve regulatory and data queries; participate in initiation, monitoring, audit and close-out visits. Participate in study team meetings, research team meetings, and ongoing protocol training/compliance meetings. Facilitate development and submission of FDA IND applications and annual reports; develop/maintain study-specific case report forms and source document tools. Provide direct regulatory/compliance guidance and facilitate investigator-initiated trials and investigator-initiated multi-site trials. Perform additional duties related to regulatory affairs as assigned. Qualifications
Bachelor’s degree (life science or human subject protection field preferred) and 3–5 years of research experience or equivalent combination; at least 1 year regulatory experience preferred. Experience with high-risk biomedical research and/or oncology regulatory research preferred. Knowledge of IRB and human research protection regulations, including ICH GCP guidelines. Strong problem-solving, communication, writing, organizational, and time management skills; able to multi-task; able to work independently or as part of a team; attention to detail; willingness to learn and grow. General computing proficiency; intermediate/advanced skills in Microsoft Office; familiarity with collaboration tools (Slack, Microsoft Teams, Zoom, WebEx, etc.). Knowledge/experience with web-based e-regulatory document management systems (eFlorence, Veeva) is a plus. Job Location
Philadelphia, Pennsylvania Department / School
Perelman School of Medicine Pay Range
$62,000.00 - $70,119.00 Annual Salary offers are based on the candidate’s qualifications, experience, skills, and education as they relate to the requirements of the position, and aligned with salary ranges based on external market data. Internal organization and peer data at Penn are also considered. Equal Opportunity Statement
The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law. Special Requirements
Background checks may be required after a conditional job offer. Consideration of the background check will be tailored to the requirements of the job. University Benefits
Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family. Flexible spending accounts are available for eligible health care and dependent care expenses with pre-tax dollars.
Tuition : Tuition assistance for employee, spouse, and dependent children; dependent children may also be eligible for tuition assistance at other institutions.
Retirement : Generous retirement plans (Basic, Matching, Supplemental) with a range of investment options through TIAA and Vanguard; options for pre-tax or Roth contributions.
Time Away from Work : Substantial paid time off to accommodate personal needs, vacations, illness, or family obligations.
Long-Term Care Insurance : Optional long-term care insurance in partnership with Genworth Financial; underwriting rules apply for eligible family members; newly hired employees may apply without health evidence.
Wellness and Work-life Resources : Programs and resources to support health, family, and work-life balance.
Professional and Personal Development : Resources to advance professional and personal growth.
University Resources : Access to libraries, athletic facilities, cultural activities, and on-site events; many activities may be accessed by you and your family.
Discounts and Special Services : Discounts on arts, entertainment, transportation, mortgages, cellular plans, movie tickets, and theme park admissions.
Flexible Work Hours : Flexible work options to balance work and personal commitments.
Penn Home Ownership Services : Forgivable loan for eligible employees for home purchase or improvements.
Adoption Assistance : Reimbursement for eligible adoption-related expenses up to two adoptions per household.
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay
#J-18808-Ljbffr