Job Description
Provide data management support to faculty members/research team in conduct of clinical trials research projects; Responsible for data management in Solid Tumor Program; Provide study coordination with investigator initiated and commercially sponsored trials; Collect quality data in timely fashion recording data on case report forms and entering into database; Work closely with staff and biostatistical core to ensure compliance and assist in the analysis of data; Register patients to trial in Clinical Trials Database/with Sponsor after confirmation of eligibility; Abstract data on patients from various sources. Under direction of team supervisor, successfully interact with cooperative group and its liaisons; Adverse event reporting; Insure compliance with GCP, FDA, ICH and IRB regulations/guidance/policies; Prepare Data Safety and Monitoring reports.Bachelors degree in health related field with 1-3 years of data management experience or equivalent work experience. Ability to interpret patient records and collate information for case report forms and databases. Effective communicator and strong interpersonal skills. The ability to comply with standard processes and willingness to learn and apply federal and local regulations for clinical trials. Interact effectively with physicians and staff. Knowledgeable in medical terminology. Strong organizational and project management skills, excellent written and verbal communication skills, with great attention to detail and a willingness to learn new skills. Some experience with databases and competent basic computer skills.The University of Michigan is an equal opportunity/affirmative action employer.
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