Clinical Research Coordinator II Oncology

SummaryAt Lumi Research, we strive to give urgent and comprehensive service to our community-based oncologists as they deliver cutting edge treatment to an under-served population. The primary purpose of the Oncology Clinical Research Coordinator II is to provide independent and functioning oversight and execution of research related events including but not limited to regulatory, patient consenting/registration, data and specimen collection for clinical trials. The candidate will assume primary responsibility for patient consenting, patient registration, data collection and data entry and will prepare regulatory reports for trial monitoring. This candidate will help oversee training of new team members and sign off on training checklists, schedule trainings and create training material as needed. This position influences the successful onboarding of clinical trial patients for the protocols executed by Lumi Research and its clinician partners.Salary range for ideal candidate: Based on experience plus enrollment bonusEmployment Status: Full time, not eligible for overtimeMon-Fri on-site HQ or SE ClinicSkills required for success:

• Proficient in oncology medicine and practice
• Able to work independently using past knowledge acquired through experience
• Think critically and quickly to resolve any logistical problems
• Communicate effectively and professionally (to clinicians, sponsors and especially patients)
• Able to work in an organized manner and follow up with pending items
• Able to multitask and use resources efficiently RequiredRoles and Responsibilities Regulatory and Administrative
• Coordinates and attends study initiation visits/planning
• Maintains the most current versions of the protocol and corresponding documentation especially the patient treatment consent and all other documents per protocol
• Coordinates clinical trial auditing and monitoring and prepares all pertinent reports as requested by the monitor
• Collects, documents and maintains knowledge of adverse events for patients on a clinical trial
• Report all adverse events, including serious adverse events as required per protocol sponsor
• Assists with protocol annual review process by collecting data and compiling required toxicity reports if applicable
• Maintain the delegation of authority logs and training logs for the protocols
• Maintain the screening log/consent log with the pertinent dates including off study dates and reason(s) for off-study/screen failure etc.
• Maintains a highly organized regulatory sharepoint folder across all protocols o Provide feedback on efficiency as needed
• Organizes all necessary data for audits
• Obtain and sustain knowledge of all electronic data capturing (EDC) systems as well as patient registering systems required per protocolStudy Coordination
• Coordinates, assesses and follows all patient activities while enrolled in clinical trials
• Creates screening logistical processes to facilitate in successful onboarding of new patients on a clinical trialo Organize and collect institutional/facility contact list to facilitate logistical obstacles
• Obtains all informed consents for patients as directed by the investigatorso Treatment consentso Tissue/Specimen collection consents
• Educate patients on trial requirements and treatment planning and review with clinic staff as needed
• Maintains current knowledge of required procedures per protocolo Create necessary checklists as neededo Train clinic staff for scheduling collaboration
• Coordinate all research visits for patients on a protocol including but not limited to:o Screening visitso Tissue collection logistics (deliver kits and schedule for pick up as needed)o Treatment-related visits- Imaging, Labs, Exam, etc.
• Organize all paper source documentation for protocol patientso Maintain electronic copies as needed in an organized manner
• Ensures that all data is collected and entered in the protocol’s EDC
• Trains staff on protocol requirements (document on training log)o Review eligibility requirements with clinic staff to assist in screening of patients
• Develop a process for internal QA to facilitate recurring monitoring visitso Answers all monitor queries
• Capture all deviations and document in a deviation log as needed per protocolo Capture corrective action plans and train staff as needed
• Administer questionnaires if required per protocol
• Ensures that patient tracking is optimal throughout the length of each trialo Treatment cycle dateso Labs, tissue collection dates and statuseso Data collection/entry
• Assist with PI oversight by maintaining the above patient tracker and be able to deliver accurate patient status during recurring investigator/sponsor meetings as neededTrainer Duties
• Serve as a preceptor for new hires
• Maintain training checklists and ensure training is available for new hires
• Create new training material as needed
• Schedule training sessions as required per protocolRequired Education:Bachelor’s degreeRequired Experience:
• 2 -3 years of experience in oncology - Work in clinical trial research, bench work research, and/or clinical experience obtained through any direct-patient care work is included.
• Can substitute required education degree with additional years of experience.
• Will consider higher education (master’s, PhD, MD, etc) if less than 2-3 years of oncology experience Benefits Overview
• Two weeks PTO per year
• Medical benefits monthly stipend for employee
• 401K with employer matching