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Clinical Program Coordinator I

Medical College of Wisconsin

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Last Updated: 10/21/21

Job Description

Position Description:

The Medical College of Wisconsin brings a synergy between the best medical education, research and patient care. Tomorrow’s discoveries happen right here alongside the very people who bring those lessons to our students. Every bit of knowledge, and every advancement, provides our students with an unprecedented, collaborative learning environment, and helps improve the vitality and care of our communities.

In the role of Clinical Program Coordinator I working in Milwaukee, Wisconsin. In conjunction with the Cancer Center Clinical Trials Office (CTO) Education/Quality Assurance Manager, the CTO Quality Assurance Coordinator is responsible for continued implementation and maintenance of quality assurance guidelines and training. Emphasis on internal monitoring of investigator-initiated trials, for cause and random auditing of records and identifying potential knowledge gaps.

Responsibilities:

  • The primary responsibility of this position would be to perform quality assurance reviews of trials supported by the Cancer Center CTO.
  • Implementing quality assurance guidelines and SOPs for investigator-initiated trials and partnering entities.
  • Coordinate quality assurance checks within the OnCore Clinical Trials Management System.
  • Provide appropriate, unbiased written and verbal reports of quality assurance findings to study team and partnering entities.
  • Possess a clear understanding and ownership of regulatory, institutional, and CTO policies, procedures, and standard practices.
  • Work closely with the CTO staff to oversee activities including regular meeting schedules, timeliness of data submission, accuracy of data and compliance to protocol, institutional and federal regulatory requirements.
  • Assist in the development of educational quality improvement materials and training based on quality assurance findings.
  • Work with the CTO staff for audit preparation.
  • Assist with development of training materials and competencies for research staff particularly orientation/training of new staff and monitoring of comprehension of their new role, as well as addressing continuing education needs for current staff.
  • Assist in development of continuing education workshops for clinical research coordinators, clinical research associates, and regulatory coordinators to include topics of adverse event and serious adverse event documentation, proper eligibility screening, research imaging procedures, source documentation standards, research chart structure as well as other topics as emerge


Preferred Schedule:
08:00a-04:30p


Position Requirements:

Minimum Qualifications:

Appropriate experience may be substituted for education on an equivalent basis

  • Minimum Required Education: Bachelor's degree in field relevant to the program
  • Minimum Required Experience: 2 years in clinical research or equivalent.

  • Preferred Education: Bachelor of science
  • Preferred Experience: Clinical research or equivalent. Experience in educational and/or audit program development and implementation preferred.
  • Field: Science based program preferred

Why MCW?

  • Outstanding Healthcare Coverage, including but not limited to Health, Vison, and Dental. Along with Flexible Spending options
  • 403B Retirement Package
  • Competitive Vacation and Paid Holidays offered
  • Tuition Reimbursement
  • On campus Fitness Facility, offering onsite classes.
  • Additional discounted rates on things as: Select cell phone plans, local fitness facilities, Milwaukee recreation and entertainment etc.

For a full list of positions see: www.mcw.edu/careers

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

Science and Research

Clinical Research Coordinator

Yearly

2 years

Yes

No

Milwaukee, Wisconsin, United States

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Company Details

Medical College of Wisconsin
Milwaukee, Wisconsin, United States