The primary purpose of the Clinical Research Coordinator III (CRCIII) is to assist and support MDs and PhDs on their research and independently coordinate Phase I-III therapeutic and non-therapeutic adult and/or pediatric clinical research for local investigator initiated and pharmaceutical sponsored trials. A CRC ensures patient safety, protocol compliance and data integrity. Level of expertise may be measured by the level of complexity of trial portfolio: typically coordinating high risk and highly complex trials. Maintain a current and working knowledge of gynecologic cancers and their relative standard of care treatment and clinical research. Maintain a current knowledge and apply all recognized ICH Good Clinical Practice (GCP) Standards and Health Insurance Portability and Accountability Act (HIPAA) regulations to the conduct of CTO Clinical trials.
Independent Trial Management/Coordination as a Subject Coordinator 35% Establish and maintain an understanding of each assigned trial including the related cancer diagnosis and standard of care treatment. Review Gyn Onc patient charts prior to clinic visit to determine eligibility for available clinical trials. Creates lists and meets with investigators to discuss enrollment. Provides research related information and recruitment information to providers. Assist Principle Investigators and treating physicians to identify eligible subjects for registry and non-therapeutic industry and local physician initiated trials. Participate in consenting process including interpretation of the study for patients and families and other healthcare providers. Provide each trial with protocol required coordination and scheduling procedures for screening and randomization and enrollment. Administer study questionnaires and surveys to subjects. Provide recruiting tools to providers, including APPs on open and pending trials. Assure study compliance throughout each trial’s life cycle from startup, open to accrual, closed to accrual, follow up and final close out. This requires maintaining research regulatory knowledge and ongoing collaboration with CTO regulatory department, study sponsors and Principle Investigators for any amendments or changes in eligibility, consenting or study treatment. This includes any affiliate site or satellite participation in assigned trials. Maintain routine communication of trial and subject status and any issues or needs with PI, co-investigators, local study team, coordinating centers and sponsors throughout the trial’s coordination. Provide insight on which trials to take on, where we are lacking, where new trials would fit in the portfolio. Communicate with investigators on potential studies and study start-up needs. Assist in the submission of documents for IRB and CPRC review and approval, including annual renewals. Report SAEs to sponsor, IRB, CPRC, DSMB and FDA as required.
Data Management 25% Abstract data from medical records and other source documents to complete the subject case report forms as participants proceed on trial. Maintain a working knowledge of medical terminology, critical lab values, understanding of medical conditions and the Common Terminology Criteria for Adverse Events (CTCAE version 4.0) As needed, correspond with off- site clinics and hospitals medical records and other source information for subject data management. Maintain study files and subject documents for each trial that is organized, accessible and retrievable. Review survival data and disease status during required subject follow up that may include family contact and public record/obituary searches Maintain understanding and technical capability of REDCap and various sponsor electronic data capture systems to ensure complete, accurate, timely submissions and quality data for each assigned trial. Maintain all required subject and study data in REDCap and TASCS (and others as identified) research systems including subject screening, registration, visit tracking, deviations and SAE reporting. Facilitate and participate in local and sponsor monitoring/audit activities including scheduling, arranging EPIC access, preparing data and resolving identified data queries. Assist with additional data requests from sponsors and PIs as requested during the trial and for local trial data analysis including meeting interim and data lock deadlines.
Assist with study procedures in collaboration with Nurse Coordinators and other research & clinical staff 15% Provide support and collaboration for non-nursing activities for subjects on therapeutic industry sponsored and local investigator initiated trials. Establish and maintain an understanding of each assigned trial including the related cancer diagnosis and standard of care treatment. On occasion may be asked to retrieve and transport specimen samples to the ObGyn Labs.
Administrative and Other 15% Act as a resource to research fellows, residents, medical students and laboratory personnel for research activities Present strategic plans and processes to faculty for greater trial enrollments Participate in Clinical Translational Working Group (TWG) meetings and meeting planning.
Lead mentor and training role for new CRC hires and clinical support staff 10% Participate in implementation and training for new processes and procedures for CRC or support staff. Provide process Improvement and CRC perspective for workflow improvements individually or as part of a defined work group. Manage additional work load and trials during staff changes or need. Complete special data management requests and special projects as assigned.
All required qualifications must be documented on application materials
Required Qualifications: BA/BS in a scientific or health related field with at least 4 years of clinical research experience or an advanced degree and 2 years experience or a combination of related education and experience in clinical research to equal 8 years.
Strong clinical background
Familiarity with University of Minnesota, UMN Medical Center and Fairview hospitals, UMPhysicians, M Health
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.