Clinical Research Professional 4: GI Division, WISDOM Study

Job Title: Research Professional 4 - Women's Health in Inflammatory Bowel
Disease (IBD)

Position Overview:
The University of Minnesota's Department of Gastroenterology, Hepatology and
Nutrition is seeking a Research Professional 4/Project Manager to coordinate and
manage clinical research projects focused on women's health in Inflammatory Bowel
Disease (IBD). The primary role of this position involves managing two major projects:
the Women with Inflammatory Bowel Disease and Motherhood (WISDOM) study, a
prospective registry studying the impact of IBD (including Crohn's disease and
ulcerative colitis) on fertility and early pregnancy outcomes.

The WISDOM study is a collaborative effort between the University of Minnesota and
Mount Sinai School of Medicine in New York City. This registry, which is primarily online
based and does not involve biospecimen collection, recruits participants across North
America. Participants complete online questionnaires about their health histories,
symptoms, treatments, and sign an authorization to release their medical records. The
research project manager will be responsible for screening provider schedules to
identify potential participants, obtaining medical records, entering data into REDCap,
and maintaining ongoing communication with participants, mainly through email and
telephone.
Additionally, this position may involve managing an IBD pregnancy registry, an
international multi-institutional research initiative studying women's health outcomes in
IBD, with similar responsibilities as those outlined for the WISDOM study.
This full-time, three-year position provides a unique opportunity to contribute to
groundbreaking research in a collaborative academic environment. The position offers
flexibility for hybrid or remote work.

Job Duties and Responsibilities:
1. Manage Clinical Research Studies (50%)

* Oversee the WISDOM registry and other IBD-related studies, including
recruitment, informed consent, treatment interventions, and HIPAA compliance.
* Screen provider schedules to identify potential participants, obtain and review
medical records, and enter relevant data into REDCap.
* Serve as the primary point of contact for participants, providing instructions,
reminders, and support via email and phone.
* Monitor study progress, ensure participant engagement, and maintain tracking
systems.
* Complete sponsor case report forms (CRFs) and adverse event logs and ensure
proper documentation of all study activities.
* Coordinate study visits, ensuring compliance with study protocols and timelines.

2. Study Regulatory Management (30%)
* Prepare and submit IRB applications, informed consent documents, and
regulatory forms for both WISDOM and IBD pregnancy registry studies.
* Maintain accurate and organized study documentation, including delegation logs
and financial disclosure forms.
* Ensure compliance with regulatory requirements and sponsor expectations.
* Track and report on the status of ongoing studies and participant enrollment.

3. Protocol Development (10%)
* Assist in writing and editing research materials, including IRB submissions, study
protocols, consent forms, and manuscripts.
* Contribute to process improvements and workflow enhancements for efficient
study management.
* Participate in regular weekly meetings with study staff at the University of
Minnesota and Mount Sinai School of Medicine to discuss project progress.

4. Data Management (10%)
* Manage participant data and questionnaires in the REDCap system.
* Ensure accurate data entry, quality control, and generation of reports in line with
study requirements.
* Collaborate with team members to assess and report on data quality and
completeness.

All required qualifications must be included in the application materials

Qualifications:
Required Qualifications:
* Passion for women's health and IBD research.
* Bachelor's degree (BA/BS) with at least 5 years of research experience, or an
advanced degree with 3 years of experience, or an equivalent combination of
education and experience to equal at least 9 years
* Experience with medical record review and working with clinical data.
* Familiarity with operating and building projects in REDCap and data
management system.
* Strong communication skills, both written and verbal, with an ability to interact
compassionately with participants.
* Proven ability to work independently and collaboratively within a team
environment.
* Strong organizational and time management skills, with attention to detail and
deadlines.
Preferred Qualifications:
* Familiarity with IRB processes at the University of Minnesota.
* Experience with statistical analysis or a background in statistics.

About the Department:
The Department of Gastroenterology at the University of Minnesota is committed to
advancing research in gastrointestinal diseases, with a focus on improving patient
outcomes and understanding complex conditions like Inflammatory Bowel Disease.

Pay Range: $71,000-$75,000 annually; depending on education/qualifications/experience

Time Appointment: 75%-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

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 employ@umn.edu or call (612) 624-8647.

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

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.

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.

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