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Clinical Trials System Support Specialist

Medical College of Wisconsin

Last Updated: 9/04/21

Job Description

Position Description:

Purpose

The Office of Research helps to facilitate life-saving biomedical research at the Medical College of Wisconsin. Nine distinct units provide specialized support to meet the administrative needs of our investigators and research staff, and together we coordinate, regulate, and monitor research studies. Within our Research Systems unit, our technical team provides front and back end support for the institutions primary research applications including OnCore Clinical Trials Management System.

The Clinical Trials Support Specialist functions as a customer-facing subject matter expert (SME) for the OnCore system, specifically for calendar and form building and modifications. The Specialist works with the OnCore Administrator and study teams to design, develop, test, and release study calendars and custom electronic case report forms. The Specialist provides end user training and support related to the comprehensive clinical research applications. The Specialist also participates in evaluation of new OnCore versions, patches, and maintenance upgrades and testing as needed.

Primary Functions

  • Applies standards and best practices in the implementation and deployment of OnCore calendars and electronic case report forms.
  • Develops and follows a standard operating procedure (SOP) for releasing study calendars, including an SOP to capture and develop study calendars for investigator initiated trials (IITs).
  • Develops and follows SOPs for eliciting, capturing, and validating questions and information to create electronic case report forms (eCRFs).
  • Develops strategies and work plans for OnCore related tasks.
  • Owns the build of assigned OnCore protocols (protocol info, specifications, budgets, and electronic data collection forms) to completion.
  • Assists the study team with initial OnCore training and use, as needed.
  • Evaluates requests to determine feasibility; researches and identifies options that best serve informatics and research needs.
  • Provides information about how requirements may affect functional design documents.
  • Participates in acceptance testing to ensure client/user needs are met.
  • Collects information regarding support requests and tracks and responds to questions from business and study team members.
  • Identifies potential problems that may arise with new or enhanced applications; communicates how problems will affect downstream users.
  • Possesses general knowledge of the Research environment at Medical College of Wisconsin.
  • Performs other duties as assigned.
  • Assists with researching opportunities to minimize complexity by leveraging current informatics investments and seeking out cost effective solutions.
  • Participates in change management activities, including Quality Assurance and testing, troubleshooting, and investigation.
  • Assists with task automation and process improvements as directed.



Preferred Schedule:
8:00 a.m. - 5:00 p.m.


Position Requirements:

Knowledge – Skills – Abilities

Provides advanced level of support, expertise, communication and coordination of assigned deliverables. Ability to effectively communicate ideas in both technical and user-friendly language. Excellent listening, written, and oral communication skills.

Has experience with the design of data collection tools for clinical trials to meet endpoint analysis expectations. Knows the methods and mechanics of the job and is able to exercise and use this knowledge under general instructions. Is a mentor to other professionals providing guidance and direction.

Work is performed independently under general supervision. Plans work according to established standards. Strong critical thinking, problem solving and attentiveness to detail required.

Organizational Structure

Building: MACC Fund Research Center (MFRC); flexibility for virtual and/or hybrid work is included in this role.

Department: Research Office

Division: Educational Services Support

Reports to (Title): Enterprise Research Applications Manager

Direct Reports (Titles): None

Collaborates with (Titles): Enterprise Research Systems Administrator and OnCore developer

Specifications

Appropriate experience may be substituted on equivalent basis

Minimum Required Education: Bachelor's degree

Minimum Required Experience: 2 years

Preferred Experience: Experience with clinical trials operations, study calendars, familiarity with OnCore (CTMS), experience using or creating case report forms and content

Field: Clinical research, scientific research, biostatistics

Commitment to Diversity

MCW is one of the largest healthcare employers in Wisconsin. We are committed to creating an inclusive and welcoming workplace that includes individuals with diverse backgrounds and experiences. We believe that embracing human differences is critical to realize our vision of a healthier world, and we recognize that a healthy and thriving community starts from within. We strive to integrate our human and social differences into MCW’s functioning, strategies and culture to create a diverse and equitable workplace. If you believe embracing individuality and working together makes us stronger, then MCW is the place for you. People of color, women, LGBTQIA+, veterans and persons with disabilities are encouraged to apply.



About MCW
The Medical College of Wisconsin (MCW) is one of the largest healthcare employers in Wisconsin. We are a distinguished leader and innovator in the education and development of the next generation of physicians, scientists, pharmacists and health professionals; we discover and translate new knowledge in the biomedical and health sciences; we provide cutting-edge, collaborative patient care of the highest quality; and we improve the health of the communities we serve.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.



Company Details

Milwaukee, Wisconsin, United States