Clinical Research Nurse
Fullerton, CA
TalentBurst, Inc
5x8 hrs, Days

PHASE 1 Clinical Research RN
CCRC Preferred

Computer Skills:
IDX, Meditech, NextGen, PACS experience a plus
Bilingual English/Spanish a plus.

This role will be involved with clinical trials centered around Rheumatology. Rheumatology, Oncology, Inpatient Studies, CAR-T experience all highly preferred. Please review JD and UD carefully with applicant.

This position is being posted based off a 6 month grant. This is a 6 month position and RN will be expected to join trial with a strong foundation of Clinical Research Knowledge. This is a great opportunity to work with a large West Coast Health System and participate in meaningful work supporting Rheumatology patients. Role is both Patient Facing & Administratively-Based.

Experience:
2 years Clinical Research experience preferred
3 years Sub Specialty Nursing Experience in an acute care/ambulatory setting preferred. 2 YEARS REQUIRED.


Job Summary:
The Clinical Research Nurse has working knowledge of clinical research activities and is responsible for the coordination of clinical research protocols, working under compliance with federal regulations, good clinical practice (GCP), Institutional Review Board (IRB) guidelines, department standard work, and performance within their scope of practice.

Essential Functions:
Coordinates research activities in consultation with the Investigator, Research Program Manager, protocol and sponsor in a safe, efficient and cost effective manner.
Trains and assists CRC I/II as necessary.
Ensures study binders for each participant in a study is complete and accurate.
Attends investigators meetings as required.
Per Investigator s orders, provides patient and family education regarding study requirements, risks/benefits/side effects of investigating agents, provided information on the Investigational Subjects Bill of Rights, Use and Disclosure of Protected Health Information and obtains written informed consents.
Performs data collection procedures as directed by the research protocol with accurate, thorough source documentation and submits data to sponsor in a timely manner.
Networks and researches potential new studies.
Performs regulatory functions for existing and upcoming studies.
Works with PI and Research Program Manager for input to ultimately submit to local or central IRB.
Recruits and enrolls patients into various studies, working with other Physicians & Allied Health Professionals across multiple departments.
Manages monitor visits and audits
Consistently maintains organized record of all research activities, as required by the sponsor and standard work, including but not limited to regulatory documents, source documents, various tracking logs, and correspondence.

Additional Responsibilities:
Ensures secure, accurate inventory of study medications/supplies.
Ensures current temperature logs for all research medications, or delegates as appropriate and promptly reports temperature excursions to appropriate personnel.
Participates in St. Jude Heritage Healthcare work groups, meetings and activities as assigned.
Responsible for knowing their legal scope of practice and maintain clinical competence with regards to skills under license or certificate.
Supports team effort, exhibits willingness to accomplish tasks, follows through on tasks until they are completed.
Performs all other duties as assigned.
Age-Related Competencies:
Human development knowledge/skills:
Demonstrates the knowledge and skills necessary to provide care appropriate to the age of the patients served including knowledge of the principles of growth and development and psychosocial characteristics and interventions for age specific requirement of the assigned unit.
Age-specific patient needs that employee is required to understand and meet:
Demonstrates the ability to assess and interpret age appropriate data about the patient s status in order to identify age-specific needs and provide the care needed.
Additional requirements:
Demonstrates age appropriate communication skills for the patient population served.
Demonstrates knowledge of age-specific community resources.

Information Management:
Treats all information and data within the scope of the position with complete confidentiality and security. Lab, microbiology, histology, blood bank, reference lab and pathology technicians and staff shall have access to a patient s current and historical record of lab test results as necessary to provide ordered lab services. Lab managers may access complete medical record for assessment of patient in relation to laboratory procedure performed. Access to PHI shall be available only when on duty and working.

Risk Management:
Cooperates fully in all risk management activities and investigations.
 

Job Requirements & Qualifications

• Previous Charge Experience:
  -
• Years of Experience:
  5 year(s)
  Note: For Clinical: • 2 years Clinical Research experience preferred • 3 years Sub Specialty Nursing Experience in an acute care/ambulatory setting preferred
• Patient Ratio Experience:
  -
• Charting System:
  Required, Any
• Teaching Hospital Experience:
  -
• Community Hospital Experience:
  -
• LTAC Experience:
  -
• Trauma Level I Experience:
  -
• Trauma Level II Experience:
  -
• Travel Experience Required:
  No
• Certfications:Certs marked with * are preferred
  BLS, CA RN Lic, CRCC*
• Skills:Skills marked with * are preferred

  Compliance and Regulatory

  Adverse event reporting*
  Create and Maintain Study Files*
  Informed Consent facilitation*
  IRB Submission*
  Maintain Accurate and Complete Regulatory Records
  Maintain Accurate and Complete Subject Records
  Protocol Compliance*
  Setup study files (FDA 1572, Collection of CVs)*
  Site Visit Log
  Telephone Log*

  Assessment

  Centrifuge*
  Obtain 12 lead EKG/ECG
  Patient Health Questionnaire/History/Allergies
  Pipettes
  Pulmonary Function Testing*

  Work Settings

  Clinical Research Coordinator*
  Clinical Research Nurse (CRN)*
  Clinical Research Organizations

  Professional Knowledge and Skills

  ICH Guidelines Knowledge*
  Infection Control/ Universal Precautions*

  Research Specialties

  Oncology*

  Office Duties

  Patient Enrollment*
  Telephone triage and follow-up calls*

  Clinical Trials

  Phase I*
  Phase II*
  Phase III*

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