The primary purpose of the Clinical Research Coordinator III is to assist research nurses or independently manage the coordination and conduct of Phase 1-3 therapeutic and/or non-therapeutic adult and/or pediatric Oncology Clinical Research for local investigator-initiated or pharmaceutical sponsored projects. A CRC ensures patient safety, protocol compliance and data integrity. The level of expertise may be measured by the level complexity of the trial portfolio: typically coordinating high rish and higly complex clinical trials. Maintain a current and working knowledge of Solid Tumor Oncology Disease, Hematology Oncology and/or Bone Marrow Transplant and their relative standard of care treatment(s) and clinical research. Maintain a current knowledge to apply recognized ICH Good Clinical Practice (GCP) standards and HIPAA regulations for the conduct of CTO Clinical Trials. Participate in assigned independent projects to enhance the knowledge and team effectiveness including mentoring new staff, development of new procedures and processes.
Duties and Responsibilities:
Independent Trial Management/Coordination as a Subject Coordinator (30%): -Establish and maintain an understanding of each assigned trial including the related cancer diagnosis and standard of care treatment. -Assist Principle Investigators and treating physicians to identify eligible subjects for registry. -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. -Provide ongoing subject coordination while on study and into follow up including subject visit tracking, OnCore trial data management. This includes management of EPIC orders and coordination with subject’s treatment plan. -Administer study questionnaires and surveys to subjects. -Provide all required research blood and tissue specimen collection including scheduling, lab orders management, kit preparation, collection timing and coordination, initial processing and shipping or storage. Management of research specimens includes inventory control, supply organization and knowledge of the specific study laboratory manual procedures. -Facilitate required tissue samples with BioNet (surgical tissue procurement), the pathology department and for other biopsy procedures -Assure study compliance throughout each trials life cycle from startup through 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. -Maintain a high level of knowledge and expertise for assigned solid tumor and/or hematologic oncology research trial portfolio.
Data Management (35%): -Abstract data from medical records and other source documents to complete the subject case report forms as they proceed on trial. This includes baseline transplant information, hospitalization and re-hospitalization, infection reporting, toxicity assessment, disease relapse and progression reporting, adverse events and serious adverse event (SAE) reporting. -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) -Design and maintain systems for timely data collection to meet the requirements of sponsors/monitors -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 the 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 the local OnCore and TASCS (and others as identified) research systems including subject screening, registration, visit tracking, deviations and SAE reporting. -Participate with PI and Study team to prepare required IND, FDA and other regulatory 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 under direction and collaboration with Nurse Coordinator as a Clinical Research Associate (20%): -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. -Maintain a working knowledge of patient eligibility and study specific requirements and procedures for each assigned trial. -Act as a secondary informational source for assigned trials to field protocol questions or potential and enrolled study subjects. -Provide back up support and coverage to nurse research coordinator as needed or requested. Participate in consenting/screening process with research coordinator and PI. Participate in recruitment and pre-screening efforts to promote trial enrollment and accrual. -Manage industry sponsored Central EKG requirements that include initial straining, performing subject EKG and transfer of data. -Manage industry sponsored Centralized CT/MRI data transfer that includes facilitating CDs and data transfer. Provide all blood and tissue specimen collection as defined previously as a subject coordinator -Assist in the delivery of Investigational Drug Pharmacy dispensed study drug to the clinical setting for subjects to receive from nurse or PI. -Administer study questionnaires and surveys to subjects.
Lead mentor and training role for new CTO hires (15%): -Provide process improvement and CRA perspective for workflow improvements individually or as part of a defined work group (eg Work CTO Labor Assumptions). -Participate in OnCore Data base upgrades and expanded applications including special projects and test environment manipulation. -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.
BA/BS in a scientific or health related field plus 4 years clinical research experience or an advanced degree and 2 years’ experience or a combination of education and experience in clinical research to equal to eight years
Oncology experience in a clinical or research setting
Experience with data abstraction and management
Experience with Epic or similar electronic medical record system
Experience with recording data in electronic case report form systems.
Experience with Word, Outlook, and web based systems for tracking activities, calendaring, and retrieving/updating information.
Clinical Research certification or equivalent
Strong clinical background
Familiarity with the University of Minnesota, University of Minnesota Medical Center Fairview hospital and clinics
Knowledge, skills and abilities:
-Proficient in Good Clinical Practices (GCP’s)
-Strong analytical skills
-Detail oriented with exceptional organizational, planning, and problem solving skills
-Ability to work independently, as part of a team, and with changing priorities
-Excellent written, verbal and interpersonal skills
-Ability to sit for extended periods of time
-Ability to lead and execute initiatives
-Ability to mentor and train CRCs level I and II
Internal Number: 334457
About University of Minnesota, Twin Cities
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