Clinical Research Nurse Coordinator I

at  Sansum Diabetes Research Institute

THIS POSITION WILL FULFILL THE FOLLOWING SPECIFIC FUNCTIONS:

• Work with the principal investigator or other co-investigator(s) on clinical research studies
• Assure compliance with the protocol requirements as mandated by the sponsor, our Standard Operating Procedures (SOPs), local and/or central Institutional Review Boards (IRB), and the U.S. Food and Drug Administration (FDA)
• Providing nursing care to research study patients:
• Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine eligibility requirements for each study
• Performs medical tests, including but not limited to vital signs, imaging studies, electrocardiograms, IV line insertion, and blood draws
• Administers investigational medications and performs patient assessments during clinic visits to determine presence of side effects and notifies Principal Investigator accordingly
• Provide education and information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment
• Documents medical and study data appropriately in patient charts/source documents to capture study requirements
• Ensures assigned studies are conducted in accordance with FDA, OSHA, and Good Clinical Practice (GCP) guidelines in the following capacities:
• Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
• Develops accurate and appropriate source materials and ensures compliance from site staff
• Provides accurate and timely data collection, documentation, and reporting in both sponsor and site databases
• Ensures appropriate credentialing and training of all staff members delegated to each study
• Supports the regulatory staff in the maintenance of regulatory documents in accordance with SOPs and applicable regulations
• Interfaces with research subjects to support efforts to determine eligibility and consenting according to each protocol
• Communicates study-specific requirements to the research team, including internal and external parties, sponsors, monitors, Principal Investigator and study subjects
• Provides ongoing quality control audits including maintaining investigational drug and device accountability
• Collaborates with study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance
• Other duties as assigned

QUALIFICATIONS

The incumbent must be able to perform each essential duty satisfactorily. Appropriate training will be provided where necessary, and specific assistance in refreshing the incumbent in those areas where appropriate. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Expert at starting IVs, pediatric experience highly desirable
• Knowledge of accepted clinical research practices, including universal precautions, GCP, human subjects research protocols, and HIPAA requirements
• Knowledge of medical terminology and drug dosage calculation
• Ability to work independently and with careful attention to detail
• Excellent multi-tasking, organizational skills and ability to manage deadlines under pressure
• Excellent oral and written communication skills
• Ability to identify and solve problems with demonstrated initiative
• Proficiency in Microsoft Office, electronic health systems and databases used in research environments
• Must be able to establish rapport and communicate with subjects of diverse cultural and educational backgrounds.

EDUCATION AND EXPERIENCE

• Current RN license
• Bachelor of Science in Nursing or other scientific disciplines desired
• At least one year of experience in clinical research settings
• CCRC or other clinical research certification desired

LANGUAGE SKILLS

The ability to read, write, and speak English clearly is mandatory. The ability to interpret documents such as safety rules, SOPs, and procedures is critical and an understanding of and ability to communicate in scientific language is desired. Spanish proficiency and/or fluency desired.

WORK ENVIRONMENT

The work environment would be generally described as an office setting with clinical facilities adjacent to the primary work area and laboratory facilities on a different floor. The ability to move within all three of these areas may be required in the execution of the employee’s functional activities. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate and the illumination of the work area is primarily with fluorescent artificial lighting.
This position is associated with exposure to biohazardous materials and communicable disease requiring the use of universal precautions at all times as well as other conditions common to a medical clinic and research facility.
This job description is intended to describe the general requirements of the performance of the job. It is not a complete list of duties, responsibilities or requirements. Other duties not listed here may be assigned as needed

ESSENTIAL DUTIES AND RESPONSIBILITIES

In close collaboration with the Principal Investigator and Director, Clinical Research Operations, incumbent will serve as a Registered Nurse on various clinical research studies and will ensure that the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state, local, Institutional Review Board (IRB), and organizational regulations. This position is primarily responsible for the accurate planning, preparation, and completion of study activities including visit procedures and collection of information from study subjects according to protocols as well as protecting the health, safety, and welfare of study subjects in both a clinical research coordinator and nursing capacity.

The incumbent must be able to perform each essential duty satisfactorily. Appropriate training will be provided where necessary, and specific assistance in refreshing the incumbent in those areas where appropriate. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

• Expert at starting IVs, pediatric experience highly desirable
• Knowledge of accepted clinical research practices, including universal precautions, GCP, human subjects research protocols, and HIPAA requirements
• Knowledge of medical terminology and drug dosage calculation
• Ability to work independently and with careful attention to detail
• Excellent multi-tasking, organizational skills and ability to manage deadlines under pressure
• Excellent oral and written communication skills
• Ability to identify and solve problems with demonstrated initiative
• Proficiency in Microsoft Office, electronic health systems and databases used in research environments
• Must be able to establish rapport and communicate with subjects of diverse cultural and educational backgrounds