Job Title: Research Professional 4 â“ Womenâ™s Health in Inflammatory Bowel
Disease (IBD)

Position Overview:
The University of Minnesotaâ™s Department of Gastroenterology, Hepatology and
Nutrition is seeking a Research Professional 4/Project Manager to coordinate and
manage clinical research projects focused on womenâ™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 Crohnâ™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 womenâ™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%)

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

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

3. Protocol Development (10%)
ï‚· Assist in writing and editing research materials, including IRB submissions, study
protocols, consent forms, and manuscripts.
ï‚· Contribute to process improvements and workflow enhancements for efficient
study management.
ï‚· 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%)
ï‚· Manage participant data and questionnaires in the REDCap system.
ï‚· Ensure accurate data entry, quality control, and generation of reports in line with
study requirements.
ï‚· 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:
ï‚· Passion for womenâ™s health and IBD research.
ï‚· Bachelorâ™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
ï‚· Experience with medical record review and working with clinical data.
ï‚· Familiarity with operating and building projects in REDCap and data
management system.
ï‚· Strong communication skills, both written and verbal, with an ability to interact
compassionately with participants.
ï‚· Proven ability to work independently and collaboratively within a team
environment.
ï‚· Strong organizational and time management skills, with attention to detail and
deadlines.
Preferred Qualifications:
ï‚· Familiarity with IRB processes at the University of Minnesota.
ï‚· Experience with statistical analysis or a background in statistics.
 

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.

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