CLINICAL RESEARCH ACTIVATION COORD RN - HOAG CENTER FOR CLINICAL RESEARCH

at  Hoag Memorial Hospital Presbyterian

Salary Range: $47.7200 - $73.3700 /hour. Actual compensation may vary based on geographic location, work experience, skill level, and education.
The Clinical Research Activation RN will support and participate in the overall startup activities for the Hoag Center for Clinical Research (HCCR) within Hoag Memorial Presbyterian Hospital. Provides support and coordination for FDA regulated research including drug/device/biologic studies that may involve industry-sponsored Phase I, II, III and IV clinical trials, government funded clinical research and investigator initiated clinical research. This role will help support clinical start-up activities by ensuring timelines for study activation are met.
The coordinator RN will participate in the study feasibility process working closely with department leaders to assess operational and financial feasibility. This will include the review of clinical research protocols, assessment of time allocation of staff based on the schedule of assessments, assessing requirement for special equipment and/or additional resources, etc. Additionally, this role will provide a valuable prospective in their assessment of trial protocols in the pipeline ensuring site readiness and operational ability.
This role will be responsible for managing trial priorities and the necessary tasks related to study start-up and site activation at HCCR. This includes activities related to clinical start-up processes, including but not limited to determining complexity of study, requesting clinical team systems access (i.e. EDC, IXRS web-based applications), facilitating study IP supply receipt, EPIC treatment build completion, source documentation completion, determining site locations, identifying collaborating investigators, and IP receipt are complete prior to internal “go-letter” issuance.
The coordinator RN will function as an active member of the Start-Up Team. This role will work closely with the Start-Teams and Operational Managers by identifying and mitigating obstacles for efficient and reduction om study activation timelines. Communicates project status and improvement areas with leadership in a timely manner. Supports the implementation of department-wide initiatives such as research process improvement efforts. Participates in required training and education programs. Participates in weekly research staff meetings.

EDUCATION AND EXPERIENCE

• At least four years of experience in clinical research as Clinical Research Coordinator/RN Coordinator.
• Bachelor’s degree required; Master’s degree preferred
• Previous experience working with commercial IRBs
• In-depth experience in reviewing clinical trial protocols.
• Knowledge of patient electronic medical systems and CTMS or similar system
• In-depth understanding of current medical terminology
• Familiarity with FDA’s Good Clinical Practice for clinical research
• Knowledge of all components of clinical trials/studies
• Ability to travel to multiple sites and attend off-site staff meetings, as needed

Please refer the Job description for details