Recruiting and pre-screening study participants; ensuring that enquiries made to the study phone and e-mail account are responded to in a timely fashion. Printing recruitment material for distribution and collating responses. Scheduling study visits for the study sites. Reviewing patient eligibility with Study PIs and managing study enrollment. Liaison with the study nurse(s) regarding patient scheduling, and any visit-specific questions (ie. equipment and/or study procedure). Training study staff in visit-specific procedures. Maintaining SOPs for visit-specific procedures. Reviewing CRFs for completeness after each study visit and prior to entry into the Study database and or helping to create CRFs in a Qualtric format. Editing and maintaining clinical report forms (CRFs) and ensuring that the correct CRFs are completed at each study visit. Assists in overseeing data-entry of CRFs into the study database. Storing and maintaining the security of all source documentation. Assist the study coordinator in the preparation of all regulatory documents (applications, amendments, continuing reviews, ORIOs, and adverse events). Brings to the PIs' attention any questions or issues occurring in the study. Working with the study coordinator to main version control of all study related documents. Assists in monitoring the patient recruitment and retention across the study sites, and reporting investigative team at monthly meeting. Assists in preparing adhoc reports for the investigative team as requested. Cleaning data at intermittent periods throughout the study, scoring survey instruments where necessary, and locking the dataset at the completion of the study. Assists in setting up and maintain clinical trial registry.
Comfortable working with a diverse study team and patient populations. Capable of working with multiple study principal investigators. Working knowledge of Microsoft Word, Excel, SPSS and Qualtrics Bachelor degree in a scientific or social science field and able to work both independently and have excellent interpersonal skills. Must have transportation and the ability to travel to clinic sites. Prior experience with and knowledge of cancer patients and their treatment experience; a cancer survivor would be ideal. Interest in and knowledge of acupressure therapy especially in the context of cancer treatments.
Experience recruiting study participants. Knowledge of U of M Health System policies and procedures. Knowledge of data processing including building databases, entering data and cleaning data. Knowledge of IRB and regulatory issues pertaining to multi-site clinical studies. Has an interest in complementary and integrative healthcare.
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The University of Michigan is an equal opportunity/affirmative action employer.