Integrated Resources
R&D Clin. Research Coord. RN-StartUp
Integrated Resources, Newport Beach, California, us, 92659
Job Summary:
The Clinical Research Coordinator RN - Start-Up will support and participate in the overall startup activities for the Client Center for Clinical Research (HCCR) within Client 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.
Essential Duties:
-This role will help support clinical start-up activities by ensuring timelines for study activation are met.
-The Clinical Research Coordinator RN - Start-up 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 Clinical Research 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.
-Must be able to work flexible hours/overtime to meet study deadlines and requirements.
**SEE THE ATTACHED FULL JOB DESCRIPTION**
**SEE THE ATTACHED FULL PHYSICAL REQUIREMENTS**
Required Skills & Experience: -Detail-oriented clinical research leader with five (5) or more years of clinical research experience. -At least four (4) years of experience in clinical research as Clinical Research Coordinator/RN Coordinator. -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. -Accommodates and adapts to change as environmental, organizational, workload, task, direction and other conditions change in a constructive and positive manner. -Manages conflict, disagreement and discord among and between staff and work units, while recognizing and addressing sensitivities and stakeholder needs. -Demonstrates ability to work with a diverse group of people in a manner that enables them to reach their full potential, in pursuit of organizational objectives. -Maintains knowledge of technology, tools, equipment and other devices in work area. -Demonstrates competence in technology skills required for the role, as well as ability to learn and master new skills. -Possesses the ability to listen and understand what others are saying in a diplomatic and neutral manner. -Establishes effective working relationships with others, contributing to a climate of mutual respect and cooperation sensitivity and tact, understanding own effect on the motivation, attitudes and actions of others. -Makes favorable first impressions. -Demonstrates full knowledge and understanding of concepts and procedures needed to be successful in the role, including knowledge of applicable department, organization and external rules and regulations impacting day-to-day processes. -Effectively manages people, resources, deliverables, budgets, general administration and other components of day-to-day management of functional unit or department. -Ability to speak and write effectively, demonstrates fundamental command of language, communicates well using all mediums. -Trust and Accountability, Business Acumen, Customer Satisfaction; Innovation; Inspiring leader & coach - selects and grows talented individuals. -Empower others with the authority they need to be successful. -Identifies and supports developmental initiatives and opportunities. -Takes time to mentor and support direct reports. -Recognizes and rewards people for excellent performance. Preferred Skills & Experience: -N/A
Required Skills & Experience: -Detail-oriented clinical research leader with five (5) or more years of clinical research experience. -At least four (4) years of experience in clinical research as Clinical Research Coordinator/RN Coordinator. -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. -Accommodates and adapts to change as environmental, organizational, workload, task, direction and other conditions change in a constructive and positive manner. -Manages conflict, disagreement and discord among and between staff and work units, while recognizing and addressing sensitivities and stakeholder needs. -Demonstrates ability to work with a diverse group of people in a manner that enables them to reach their full potential, in pursuit of organizational objectives. -Maintains knowledge of technology, tools, equipment and other devices in work area. -Demonstrates competence in technology skills required for the role, as well as ability to learn and master new skills. -Possesses the ability to listen and understand what others are saying in a diplomatic and neutral manner. -Establishes effective working relationships with others, contributing to a climate of mutual respect and cooperation sensitivity and tact, understanding own effect on the motivation, attitudes and actions of others. -Makes favorable first impressions. -Demonstrates full knowledge and understanding of concepts and procedures needed to be successful in the role, including knowledge of applicable department, organization and external rules and regulations impacting day-to-day processes. -Effectively manages people, resources, deliverables, budgets, general administration and other components of day-to-day management of functional unit or department. -Ability to speak and write effectively, demonstrates fundamental command of language, communicates well using all mediums. -Trust and Accountability, Business Acumen, Customer Satisfaction; Innovation; Inspiring leader & coach - selects and grows talented individuals. -Empower others with the authority they need to be successful. -Identifies and supports developmental initiatives and opportunities. -Takes time to mentor and support direct reports. -Recognizes and rewards people for excellent performance. Preferred Skills & Experience: -N/A