Data Quality Specialist

Do you want to be on the frontline of research and development fighting childhood cancer?

Do you want to contribute towards the progress of better treatment and prognosis for pediatric cancer patients?
Join our team of researchers at the Medical College of Wisconsin where we are conducting more than 100 clinical trials to better understand childhood cancers and blood disorders and find new ways to treat them.

Under the direction of the research principal investigator and Research Regulatory Specialist Sr., the Research Data Quality Specialist works collaboratively to support hematology, oncology, bone marrow transplant, and cellular therapy clinical trials for pediatric patients.

In this role you will collaborate with the research team to ensure compliance with study protocol guidelines and adherence to federal, state, and institutional standard operating procedures.

Breakthroughs in cancer treatment don’t happen overnight. They evolve after years of research in the laboratory, then in small groups of patients, and then in larger groups of patients. Be part of that fight!

Purpose

Member of the CTO Regulatory team responsible for assisting with the development of a quality assurance program that ensures compliance with Federal, State and Institutional Standard Operating Procedures. The CTO Research Regulatory Data Specialist will function as a liaison with sponsors, principal investigators, study team members and the IRB providing support to facilitate the achievement of the CTO’s goals. The Research Regulatory Data Specialist works with clinical research teams to ensure that Data Quality is compliant with local and federal regulations as well as all sponsor requirements.

Primary Functions

• Provides main administrative support for planning and performing quality control activities to assess risk and ensure adherence to institutional policies and procedures, local and federal regulations (i.e., OHRP, FDA, etc.) and Good Clinical Practices (ICH-GCP).
• Review documentation for accuracy and completeness, identify problems, and perform quality control based on established checklists prior to IRB submission.
• Support faculty with Investigator-Initiated IND/IDE applications through data monitoring activities.
• Work closely with CTO Research Managers, Research Nurses, and Research Coordinators to identify any educational trainings and resources driven by monitoring and audit findings (e.g. forms and checklists, educational training, etc.).
• Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to supervisor and study investigators.
• Assure that clinical research activities comply with various federal and state laws, and institutional standard operating procedures.
• Collaborate with investigators and CTO Research nurses/study coordinators on the development of program materials including educational materials, marketing materials, websites, forms, and reports.
• Maintain program timeline including tracking deadlines for program components. Utilize MCW’s Clinical Trial Management System (CTMS) OnCore to assist with meeting regulatory requirements and tracking activities. Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders.
• Work under the supervision of the Research Regulatory Specialist Sr. or Clinical Trials Manager to ensure that research compliance objectives are met.
• Implement quality control measures for research charts/records to ensure timeliness of data submission, accuracy of data and compliance to protocol, and adherence to all institutional, federal, and state regulatory requirements and operating procedures.
• Assist with preparation for internal/external audits and monitoring visits (MCW, Sponsor, FDA, Clinical Trials Consortia, etc.).
• Perform other duties or projects as assigned.

Knowledge – Skills – Abilities

Excellent oral and written communication skills are essential. Strong critical thinking, problem solving and attentiveness to detail required. Additional training in regulatory compliance strongly preferred.

Education: Bachelors DegreeEmployment Type: Full Time