Independently, and in collaboration with the Research Nurse, coordinates Phase I-III therapeutic adult solid tumor clinical research for local investigator initiated and pharmaceutical sponsored trials. Manages numerous study-specific databases by entering participant data and responding to sponsor queries in order to meet timelines for various analyses and ensure data accuracy. Provide ongoing subject coordination for patients who are actively on clinical trials as well as into long term follow-up phase, including OnCore subject tracking and follow-up phone calls to participants for survival data and surveys. The purpose of these tasks in conjunction with one another is ultimately to allow for comprehensive data collection and subsequent analysis of each trial carried out by our institution in the hopes of improving future cancer treatment and care.
Data Management(40%) - Abstract data from the medical records in Epic and other source documents to complete the subject case report forms necessary for each trial - Maintain a working knowledge of medical oncology terminology, critical lab values, and understanding of medical conditions - Design and maintain systems for timely data collection to meet the requirements of sponsors/monitors - Correspond with off-site clinics and hospitals to obtain research-related patient records as needed
Assist with Study Procedures under direction and in collaboration with Nurse Coordinator as a Clinical Research Coordinator (30%)
- Assist in the delivery of investigational study drug to the clinical setting for subjects to receive from the clinical research nurse - Make follow-up phone calls to patients as well as administer surveys (ie. patient satisfaction, health economics) - Maintain awareness of patient eligibility criteria and study specific requirements and procedures for each assigned trial - Verify scheduled protocol procedures to ensure ongoing protocol and organization compliance in collaboration with the nurse coordinator
Independent Trial Management/Coordination as a Subject Coordinator (25%) - Schedule all routine on-site monitoring visits to allow for sponsor data verification, drug accountability with IDS pharmacy, and meetings with investigators - Provide all required research blood and tissue specimen collections including kit preparation, collection timing and coordination, shipping and/or storage - Management of research specific supplies including inventory control, supply organization and knowledge of the specific study laboratory manual procedures - Work closely with the regulatory specialist to assure study compliance throughout each trial's life cycle (amendment updates, filing deviations, etc.)
Participate in Clinical Trials Office Working Group (5%) - Serve as a co-lead of the 'Finding the "Right" Studies' working group that aims to develop predictive tools for success in areas concerning finance, workload impact of the study team, and general trial design - Organize Finance subgroup meetings by scheduling, building agendas, and keeping the group on task with reminders of our end goal - Utilize Gantt Chart to visualize the specific milestones and timelines leading to the group's final desired outcome
All required qualifications must be documented on application material
Required: -BA/BS with at least 2 years of experience or a combination of related education and work experience to equal 6 years; position involves comparing, verifying and reconciling data to help department achieve overall objectives. -Experience with and knowledge of medical terminology. Experience abstracting data.
-Proficiency in Microsoft applications (Word, Access, Excel)
Preferred: -BA/BS in science or health related degree. -Experience recording and tracking health related or scientific data. -Experience in a clinical setting and with patient care/contact. -Experience with Allscripts, FCIS, or equivalent electronic medical records system. -Research experience. -Knowledge of medical terminology in a BMT or oncology setting. -Excellent attention to detail and organizational skills. -Ability to work independently, as part of a team, and with changing priorities. -Ability to sit for extended periods of time.
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.