Research - Laboratory/Non-Laboratory, Staff/Administrative
At University of Minnesota, our physician-researchers are developing new treatments and cures for today’s most devastating diseases and health conditions. Kidney disease is one of the leading complications of diabetes, and can lead to serious health problems. Despite many medical advances in the treatment of diabetes, kidney disease remains a significant problem and new treatments are urgently needed. The PERL study is a large international clinical trial involving patients with type 1 diabetes who have early signs of kidney injury. The trial is testing a new way to prevent diabetic kidney disease. We are also actively recruiting patients for two other clinical trials, the FIGARO and the FIDELIO studies, which aim to determine the efficacy of Finerenone in reducing the rate of cardiovascular (FIGARO) or renal (FIDELIO) events in patients with type 2 diabetes and renal dysfunction.
Position Summary: The primary purpose of this position is to oversee and coordinate all research activities for the Caramori Research Group, including but not limited to the PERL, FIDELIO and FIGARO clinical trials according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include coordinating the enrollment of eligible patients, extracting and reporting quality patient data and tissue samples, oversee activities at affiliate sites, ongoing management of regulatory needs, and managing study budget. This position reports to the Principle Investigator.
Major Duties/Job Description: Subject and Data Management (60%): • Manage the daily research activities of PERL, FIGARO and FIDELIO studies • Organize and implement subject recruitment, enrollment, and retention • Manage clinical appointments, perform non-invasive protocol procedures • Obtain data and accurately transmit to proper database • Collect, process and ship biological specimens • Maintain source documents • Facilitate the timely review and reporting of adverse reactions and severe adverse events • Anticipate and solve potential problems
Administration (35%): • Coordinate study-specific billing, verify and approve invoices • Lead weekly team meetings • Participate in study-specific conference calls • Hire, supervise and mentor employees • Ensure all members of study team complete and maintain required training • Coordinate and travel to study and site meetings as appropriate
Regulatory Management (5%): • Collaborate with the Department's regulatory specialist for all required IRB documentation. This includes initial applications, continuing reviews, protocol amendments, responding to stipulations, etc. • Prepare for and participate in site initiation visits, monitoring visits, program audits, etc.
The University of Minnesota offers a comprehensive benefits package including:
Competitive wages, paid holidays, vacation and sick leave
Low cost medical, dental, and pharmacy plans
Health care and dependent daycare flexible spending accounts
Excellent retirement plans with employer match
Disability and employer paid life insurance
Wellbeing program with reduced insurance premiums
Tuition reimbursement opportunities covering 75%-100% of eligible tuition
Student loan forgiveness opportunity
Opportunities for growth and promotion
Employee Assistance Program
For more information regarding benefits: https://humanresources.umn.edu/sites/humanresources.umn.edu/files/2018_tcd-cslr-75100-ben-0105-7.pdf
Required Qualifications (Must be documented on application materials/resume): • BA/BS in a health related field plus four years of relevant research experience; Advanced degree in a health related field plus two years of relevant research experience; or a combination of related education and work experience totaling eight years. • Demonstrate experience initiating and performing a research project, including regulatory management. • Direct experience recruiting, consenting, and interacting with human subjects; proven track record with retaining study subjects. • Demonstrated experience in supervising or leading a research team; ability to oversee team members and delegate study tasks appropriately. • Computer proficiency and ability to navigate multiple software applications; experience with computerized data management; experience reviewing and abstracting from medical records. • Proved detail-oriented with exceptional organizational, planning and problem-solving skills. • Demonstrated ability to maintain deadlines and prioritize assignments. • Excellent written, verbal and interpersonal skills; demonstrated writing skills in a technical or medical setting. • Knowledge of Good Clinical Practices (GCPs), and federal regulations related to clinical research. • Ability to work flexible work hours, including some early mornings, evenings, and weekends. • Willingness to visit regional affiliate sites as needed. • Ability to stand or walk (including stairs) for up to 2.5 hours, reach above shoulders, lift up to 10 pounds above the shoulder, and carry packages across campus at waist level.
Preferred Qualifications: • Clinical research certification and/or advanced training • Experience collecting, processing, and shipping human specimens for research • Working knowledge of UMN research policies, procedures, resources, and systems • Experience performing physical evaluations and procedures, such as vital signs, EKGs, phlebotomy
Internal Number: 327579
About University of Minnesota, Twin Cities
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.