|Job type||Full Time|
Our program seeks a Regulatory Specialist to facilitate the compliant execution of clinical trials conducted by the faculty in the division, including assistance with development and maintenance of regulatory standards within the group. This position is essential to our program's ability to provide potentially beneficial treatment options to children, adolescents, and young adults diagnosed with cancer and other blood disorders. We are looking for a knowledgeable, dedicated regulatory professional to join our collaborative, multi-disciplinary team as we continue to grow our programs and clinical research portfolio. This is an entry-level regulatory specialist position; a person in this role will initially be assigned studies in our portfolio with well-defined regulatory requirements and expectations such as registry trials, data and biorepositories, and Phase 3 cooperative group sponsored clinical trials. They will also provide regulatory support to other, more complicated studies, under the mentorship and guidance of more senior regulatory specialists on the team. We support ongoing learning and professional development to empower employees to continue to progress in their career.
Persons in this position will perform regulatory processes necessary to make clinical trials available to childhood cancer and blood disorder patients following federal regulations, as well as sponsor and University policies. This includes: creating and maintaining regulatory documents, ensuring all are filed and archived properly; creating and adapting subject consent forms in compliance with sponsor and local standards; acting as a liaison with sponsor, principal investigator, research manager, review committees and monitors (internal and external); addressing issues of study rationale, implementation, and safety monitoring; monitoring trends in regulatory/protocol processes and making recommendations for improvement.
70% Regulatory Processes for Continued Management of Active Trials
• Complete ongoing regulatory management for assigned studies including preparation and submission of protocol amendments and other study-related changes, and ensuring timely continuing reviews.
• Responsible for ensuring that all regulatory items are processed, maintained, and approved per the institutional and divisional standards for timeliness and completeness, throughout the life of the study.
• Maintain protocol information and documents in the Clinical Trials Management and eBinder systems.
• Keep regulatory documents up to date throughout the life of assigned studies. Regulatory documents can include FDA 1572, Signature and Delegation of Authority logs, Training logs, documentation of investigator CV and licensure, etc. depending on the regulations that apply to each individual study.
• Track IRB submissions, approvals, and pending expirations; ensure continuing review deadlines are met to avoid a lapse in approval.
• Maintain version control of all IRB-approved study documents.
• Coordinate processing of outside safety reports and local serious adverse events. Ensure these are reviewed by the PI and submitted to the IRB of record per institutional requirements.
• Maintain detailed regulatory binders shared electronic filing systems.
• Prepare for and participate in interim monitoring visits, closeout visits, audits, etc.
• Report Unanticipated Problems Involving Risk to Subject and Others (UPIRTSO) per IRB requirements
• Ensure regulatory files are fully compliant and audit-ready at all times.
25% Regulatory Processes for Opening New Trials
• Ensure compliance with University requirements for registering research projects, obtaining ancillary reviews, and updating study records in the Clinical Trials Management and eBinder systems.
• In collaboration with the PI and Primary Research Coordinator, interpret study protocols and develop consent form documents using provided templates, prepare IRB & CPRC and other ancillary review submissions, and respond to requests for modifications.
• Facilitate accurate and timely completion of all regulatory documents needed to initiate a study.
• Follow-up on regulatory submissions and correspondence through the institutional processes until approvals are obtained.
• Create compliant, detailed regulatory files and binders for new studies.
• Prepare for and participate in site selection and site initiation visits.
5% Process Improvement, Mentorship and Training
• Serve as the primary regulatory resource for the research teams, research sponsors, and University review committees for assigned projects.
• Engage in the development of standardized research practices and workflows within the division
• Collaboratively identify, develop, discuss, and implement new procedures.
• Attend professional development and training sessions to ensure compliance with newest policies and procedures.
• Conduct quality monitoring of regulatory files according to departmental procedures
All required qualifications must be documented on application materials
• BA/BS in a related field, and two years of relevant experience; or a combination of related education and experience to total six years
• Experience with regulations governing human subject research (such as Good Clinical Practice, FDA and other federal regulations and International Conference on Harmonization guidelines)
• Electronic document management experience and strong skills with Adobe Acrobat and Microsoft Word
• Detail-oriented with exceptional organizational, planning, and problem-solving skills
• Ability to work independently, as a part of a team, and with changing priorities
• Demonstrated ability to maintain deadlines and prioritize assignments
• Excellent written, verbal and interpersonal skills
• Previous experience as a Regulatory Specialist or Clinical Research Coordinator
• Experience interpreting medical information and developing patient-facing materials, such as consent forms and recruitment flyers
• Experience preparing and managing IRB and other regulatory review submissions
• Experience working in a pediatric or oncology clinical research setting
• Certification as a clinical research professional with Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) or willingness to obtain certification at time of eligibility
About the Department
The Division of Pediatric Hematology/Oncology supports a comprehensive clinical, research and education program with a focus on five core areas: benign hematology, leukemia, brain tumors, solid tumors (sarcomas) and childhood cancer survivorship. We offer clinical trials and innovative therapy programs to ensure the best possible outcomes for pediatric cancer patients. Our investigators have earned national and international recognition for leading-edge cancer research and comprehensive care.
How To Apply
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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.
|Employer||University of Minnesota|