The primary purpose of the Clinical Research Coordinator II (CRCII) is to assist research nurses and/or 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 low to moderate risk trials and assisting with moderate to high risk trials. Maintain a current and working knowledge of Solid Tumor and/or Hematologic Oncology Disease 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
Establish and maintain an understanding of each assigned trial including the related cancer diagnosis and standard of care treatment. Each CRAII’s trial portfolio may focus on adult and/or pediatric populations.
Assist Principle Investigators and treating physicians 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.
Provide ongoing subject coordination while on study and into follow up including TASCS subject tracking, OnCore trial data management. This includes management of EPIC/Beacon 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 BioNnet (surgical tissue procurement), the pathology department and for other biopsy procedures.
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.
Development of specific knowledge base and focus for assigned solid tumor, hematologic oncology and/or BMT-related research
Abstract data from medical records and other source documents to complete the subject case report forms as participants proceed on trial. This includes all baseline subject 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 tracking 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 local OnCore 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 the local Oncore 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 under direction and collaboration with Nurse Coordinator as a Clinical Research
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 support to nurse coordinator as needed or requested.
Participate in consenting/screening process with nurse (Subject 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. Administer study questionnaires and surveys to subjects.
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.
ll required qualifications must be documented on application materials.
BA/BS in a scientific or health related field with at least 2 years of clinical research experience or a combination of related education and experience in clinical research to equal to 6 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.
Knowledge, skills and abilities:
Proficient in Good Clinical Practices (GCP’s)
Strong analytical skills
Detail oriented with exceptional organizational, planning, and problem solving skills
Demonstrated ability to work independently, as part of a team, and with changing priorities
Excellent written, verbal and interpersonal skills
Willingness to sit for extended periods of time
Demonstrated ability to lead and execute initiatives
Demonstrated ability to mentor and train CRCs level I and II
Strong clinical background
Familiarity with the University of Minnesota, University of Minnesota Medical Center Fairview hospital and clinics
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.