The primary purpose of this position is to independently manage pediatric clinical studies according to regulatory requirements, institutional guidelines, and sponsor expectations. The Regulatory Specialist facilitates the compliant execution of clinical trials, and assists in the development and maintenance of regulatory standards within the group. Duties include comprehensive regulatory management of active and new clinical studies, facilitating study start-up, ensuring compliance with University reporting requirements, and maintaining records of investigator and staff qualifications. Clinical studies may be inclusive of Sponsored or Sponsor-Investigator studies, both single and multi-site. This position will have a strong focus in study start-up submission, along with leading the education of study staff on regulatory-related study management. This position reports to the Senior Regulatory Manager but is accountable to the program leaders, project managers, the physician-investigators, and members of the clinical research team.
Regulatory Processes for Opening New Clinical Studies (60%)
Ensure compliance with University requirements for registering research projects, obtaining ancillary reviews, and updating study records in the Clinical Trials Management and eBinders systems.
In collaboration with the PI and Primary Research Coordinator, interpretstudy protocols and develop consent form documents, prepare IRB submissions, and respond to requests for modifications.
Provides PI consultation and guidance in regulatory requirements for the development of Investigator-Initiated protocol; develop consent forms, prepare IRB submissions, respond to requests for modifications.
Facilitate accurate and timely completion of additional regulatory documents.
Shepherd submissions and correspondence through the processes until approvals are obtained.
Create regulatory files and binders for new studies.
Support the development of electronic consent forms in REDcap.
Prepare for and participate in site selection and site initiation visits. Lead project managers in identifying regulatory needs during these processes and intake.
Regulatory Management of Ongoing Clinical Studies (20%)
Ongoing regulatory management including preparation and submission of protocol amendments and other changes, and ensuring timely annual reviews.
Maintaining protocol information and documents in the Clinical Trials Management and eBinder systems.
Facilitate completion of additional regulatory documents.
Independently tracks IRB submissions, approvals, and pending expirations; ensuring deadlines are met to avoid a lapse in approval.
Maintain version control of all IRB-approved study documents.
Maintain regulatory binders and required documentation to ensure compliance with regulations, University policies, and Sponsor expectations.
Prepare for and participate in monitoring visits, program audits, etc.
Coordinate processing of outside safety reports and local serious adverse events; ensure PI assessment per IRB and sponsor requirements.
Report Unanticipated Problems Involving Risk to Subject and Others (UPIRTSO) per IRB requirements.
Independently provides the investigators and team guidance for ensuring all regulatory reporting requirements are met.
Research Education (10%)
Attend professional development and training sessions to ensure compliance with newest policies and procedures.
Serve as a lead regulatory resource for the research teams, research sponsors, and University review committees.
Mentor and be a lead resources to Clinical Research Coordinators in Regulatory Management of human subject's research.
Identify, develop and lead professional development, education and training sessions with program staff.
Quality & Process Improvement (10%)
Assist in identifying, developing, discussing, and implementing new procedures.
Supportother special projects and program initiatives as directed; may complete independently, or lead initiatives and projects with other program staff (e.g. project managers, coordinators).
Support quality assurance and monitoring on studies as assigned by Senior Regulatory Manager.
Assist with quality monitoring according to departmental procedures
All required qualifications must be documented on application materials
Required Qualifications:
Bachelorâ™s degree in health, public health, biomedical disciplines plus at least 4 years of relevant experience in clinical research; or advanced degree plus at least two years of relevant experience, or a combination of related education and work experience in research totaling eight years.
Experience with regulations governing research activity (such as but not limited to GCPs, FDA regulations and ICH guidelines).
Experience interpreting clinical research protocols.
Computer proficiency, and ability to navigate multiple software applications with electronic document management experience, especially Adobe and Microsoft.
Detail-oriented with exceptional organizational, planning and problem-solving skills
Ability to work independently, as a part of a team and with changing priorities
Excellent written, verbal and interpersonal skills
Preferred Qualifications:
Previous professional experience on a clinical research project team or similar environment , such as clinical research coordinator or research assistant or regulatory specialist
Experience in a Pediatric clinical research setting
Experience in an academic medicine setting
Experience writing and adapting patient consent forms for research studies
Experience preparing and managing IRB and other regulatory review submissions
Clinical Research certification, or willing to sit for exam within 12 months of hire
Familiarity with Clinical Trial Management Systems including OnCore and electronic regulatory systems including Florence
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.