Research Pro 1-Regulatory Affairs
About the Job
The Masonic Cancer Center's Clinical Trials Office is committed to an excellent employee experience, offering a flexible work environment that meets the needs of students, staff, faculty, and the communities we serve. Flexible work arrangements may include flexibility in schedule and/or work location. All UMN employees are expected to follow applicable public health and safety procedures. This position is remote with infrequent in-person team functions. This position is currently posted at a level 1, but candidates with the appropriate qualifications may be considered for hire at a level 2.
JOB RESPONSIBILITIES
Regulatory Management of Clinical Studies (80-100%, depending on job level)
• Provides regulatory guidance and direction to research team members to ensure compliance with all applicable policies, procedures and regulations.
• Serves as primary contact for purposes of collection, organization, completion, and retention of essential regulatory documentation.
• Collaborates with the Principal Investigator, study coordinators, and other research team members to interpret protocols and edit consent documents as needed for clinical research studies..
• Prepares FDA, IRB, and other required reviewer's applications, respond to stipulations, and shepherd applications by coordinating communications and documentation through the processes until approvals are obtained.
• Tracks all regulatory review submissions and approvals to ensure deadlines are met.
• Maintains investigator site binder (essential regulatory documents) to ensure ongoing compliance and audit-readiness.
• Reviews outside safety reports and local serious adverse events and assesses for regulatory reporting. Identifies and reports unanticipated problems involving risk to subjects or others (UPIRTSO) within the required timeline.
• Prepares for and participates in sponsor/CRO interactions and monitoring visits, which may include prequalification, site initiation, interim monitoring, and closeout visits.
• Serves as the regulatory subject matter expert through all phases of a clinical study.
• Provides input during protocol development activities with the Protocol Writer and the Principal Investigator
• Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications, which includes identification of submission needs, preparation of required forms, tracking correspondence, and record retention.
Training & Mentorship (0-20%, depending on job level)
• Participates in onboarding and training of new regulatory staff
• Mentors and coaches clinical research staff on regulatory management of human subjects research, including interpretation of policies and forms, reporting obligations, and study documentation standards.
• Identifies, develops, and implements job aids, work instructions, and workflow improvements in collaboration with CTO leadership and institutional stakeholders.
• Provides regulatory consultation for complex studies, serving as an escalation point for troubleshooting and problem-solving.
• Leads or co-leads regulatory educational events for CTO staff, including development of educational materials and periodic updates based on regulatory/policy changes.
Qualifications
All required qualifications must be documented on application materials.
Required Qualifications:
• BA/BS and minimum of 2 year of clinical research or related experience
• Knowledge of clinical research trials regulations (e.g., Food and Drug Administration [FDA] and Good Clinical Practice (GCP)).
• Knowledge of IRB policies and procedures.
• Knowledge of basic anatomy and medical terminology
• Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment
• Strong written and verbal communication skills, including computer proficiency in a PC environment with Microsoft Office products.
Preferred qualifications:
• Clinical Research Coordination certification
• Experience in oncology clinical research setting
• Previous professional experience on a clinical research project team or similar environment
• Experience writing and adapting patient consent forms for research studies
• Experience in an academic medicine setting
• Experience using UMN health sciences software and document management systems (e.g., OnCore, Florence eBinders, Smartsheet, varying IRB systems, Box, Google Workspace/G Suite)
About the Department
The Masonic Cancer Center (MCC) is an NCI-designated Comprehensive Cancer Center dedicated to cancer research, education, and patient care for the citizens of Minnesota and the surrounding region. Since the time of the first award in 1997, there has been consistent growth of the membership and research base, enabling our center to further advance our knowledge and enhance care for our catchment area. We are driven to be the choice academic healthcare environment for patients, clinicians, scientists and students who seek exceptional, compassionate, precision cancer therapy; innovative clinical trials and prevention programs; cutting-edge research opportunities; and outstanding advanced education.
Pay and Benefits
Pay Range: $55,000 - $80,000; depending on education/qualifications/experience
Time Appointment: 100% Appointment
Position Type: Civil-Service & Non-Faculty Labor Represented Staff
Please visit the Office of Human Resources website for more information regarding benefit eligibility.
The University offers a comprehensive benefits package that includes:
• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area
How To Apply
Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.
Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.
To request an accommodation during the application process, please e-mail [email protected] or call (612) 624-8647.
Diversity
The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.
The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu
Employment Requirements
Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.
About the U of M
The University of Minnesota, Twin Cities (UMTC)
The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.
At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).
Apply Now
Apply Now
The Masonic Cancer Center's Clinical Trials Office is committed to an excellent employee experience, offering a flexible work environment that meets the needs of students, staff, faculty, and the communities we serve. Flexible work arrangements may include flexibility in schedule and/or work location. All UMN employees are expected to follow applicable public health and safety procedures. This position is remote with infrequent in-person team functions. This position is currently posted at a level 1, but candidates with the appropriate qualifications may be considered for hire at a level 2.
JOB RESPONSIBILITIES
Regulatory Management of Clinical Studies (80-100%, depending on job level)
• Provides regulatory guidance and direction to research team members to ensure compliance with all applicable policies, procedures and regulations.
• Serves as primary contact for purposes of collection, organization, completion, and retention of essential regulatory documentation.
• Collaborates with the Principal Investigator, study coordinators, and other research team members to interpret protocols and edit consent documents as needed for clinical research studies..
• Prepares FDA, IRB, and other required reviewer's applications, respond to stipulations, and shepherd applications by coordinating communications and documentation through the processes until approvals are obtained.
• Tracks all regulatory review submissions and approvals to ensure deadlines are met.
• Maintains investigator site binder (essential regulatory documents) to ensure ongoing compliance and audit-readiness.
• Reviews outside safety reports and local serious adverse events and assesses for regulatory reporting. Identifies and reports unanticipated problems involving risk to subjects or others (UPIRTSO) within the required timeline.
• Prepares for and participates in sponsor/CRO interactions and monitoring visits, which may include prequalification, site initiation, interim monitoring, and closeout visits.
• Serves as the regulatory subject matter expert through all phases of a clinical study.
• Provides input during protocol development activities with the Protocol Writer and the Principal Investigator
• Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications, which includes identification of submission needs, preparation of required forms, tracking correspondence, and record retention.
Training & Mentorship (0-20%, depending on job level)
• Participates in onboarding and training of new regulatory staff
• Mentors and coaches clinical research staff on regulatory management of human subjects research, including interpretation of policies and forms, reporting obligations, and study documentation standards.
• Identifies, develops, and implements job aids, work instructions, and workflow improvements in collaboration with CTO leadership and institutional stakeholders.
• Provides regulatory consultation for complex studies, serving as an escalation point for troubleshooting and problem-solving.
• Leads or co-leads regulatory educational events for CTO staff, including development of educational materials and periodic updates based on regulatory/policy changes.
Qualifications
All required qualifications must be documented on application materials.
Required Qualifications:
• BA/BS and minimum of 2 year of clinical research or related experience
• Knowledge of clinical research trials regulations (e.g., Food and Drug Administration [FDA] and Good Clinical Practice (GCP)).
• Knowledge of IRB policies and procedures.
• Knowledge of basic anatomy and medical terminology
• Excellent organizational skills, attention to detail, ability to problem solve and to prioritize multiple competing tasks in a dynamic environment
• Strong written and verbal communication skills, including computer proficiency in a PC environment with Microsoft Office products.
Preferred qualifications:
• Clinical Research Coordination certification
• Experience in oncology clinical research setting
• Previous professional experience on a clinical research project team or similar environment
• Experience writing and adapting patient consent forms for research studies
• Experience in an academic medicine setting
• Experience using UMN health sciences software and document management systems (e.g., OnCore, Florence eBinders, Smartsheet, varying IRB systems, Box, Google Workspace/G Suite)
About the Department
The Masonic Cancer Center (MCC) is an NCI-designated Comprehensive Cancer Center dedicated to cancer research, education, and patient care for the citizens of Minnesota and the surrounding region. Since the time of the first award in 1997, there has been consistent growth of the membership and research base, enabling our center to further advance our knowledge and enhance care for our catchment area. We are driven to be the choice academic healthcare environment for patients, clinicians, scientists and students who seek exceptional, compassionate, precision cancer therapy; innovative clinical trials and prevention programs; cutting-edge research opportunities; and outstanding advanced education.
Pay and Benefits
Pay Range: $55,000 - $80,000; depending on education/qualifications/experience
Time Appointment: 100% Appointment
Position Type: Civil-Service & Non-Faculty Labor Represented Staff
Please visit the Office of Human Resources website for more information regarding benefit eligibility.
The University offers a comprehensive benefits package that includes:
• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area
How To Apply
Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.
Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.
To request an accommodation during the application process, please e-mail [email protected] or call (612) 624-8647.
Diversity
The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds.
The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu
Employment Requirements
Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from employment.
About the U of M
The University of Minnesota, Twin Cities (UMTC)
The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.
At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well as by Forbes as Best Employers for Women and one of America's Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019, 2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).
Apply Now
Apply Now