CT Rsch Nurse I Fresno, CA
The Clinical Trial Nurse I (CTN-I) is a novice level position which, under the guidance & supervision of the Principal Investigator (PI) & clinical trials administrative management, assists in ensuring that the integrity & quality of the clinical trial(s) are maintained & conducted in accordance w/ federal, state & local regulations, Institutional Review Board (IRB) approvals, & Kaiser Permanente (KP) policies & procedures.
W/ direction from the PI, this position coordinates research activities as outlined in the Major Responsibilities below. This position is also responsible for protecting the health, safety, & welfare of research participants.
Essential Functions:
- The following is done w/ guidance from PI: Compliance w/ KPNC IRB approved protocols & Good Clinical Practice (GCP), federal, state, & local regulations, & KP policies & procedures.
- W/ direction, assist w/ any internal/external compliance monitoring &/or audits & inspections to protect research participants, assure operational effectiveness of the program, & to reduce risks to the organization.
- Utilize nursing skills to coordinate research-related activities (e.g., consenting, eligibility work up, scheduling study visits, assisting w/ nursing assessment of participants, adverse events, & data collection including laboratory & diagnostic studies).
- Perform nursing procedures required in the protocol, & report all protocol violations/deviations & adverse events to the PI in a timely manner to ensure the health, safety & welfare of the participants.
- Recruitment for potential participants.
- Abstract data from source documentation onto case report forms (paper or electronic) in a timely manner.
- Assist w/ study completion, resolution of data queries, data lock, study closeout, & archiving of study files.
- Communicate & collaborate w/ study team including internal & external parties, Sponsors, PI, clinical trials administrative management, study participants, & KPNC Offices of Clinical Trial Compliance & Operations.
- Assist others w/ the maintenance of systems & resources for the effective communication & submission of required documentation to the IRB.
- Participate w/ PI & KFRI to identify & prioritize the development of clinical trials systems & infrastructure to maintain research quality & compliance at clinical trial sites.
- No supervisory responsibilities.
- Other duties as assigned by appropriate management.
Secondary Functions:
- Responsible for assisting in the informed consent process, screening potential patients for adult oncology clinical trials
- Assessing treatment patients for toxicities; dose modifications, and serious adverse events; patient/family/medical/nursing staff education
- Assist physicians' in tumor assessments of subjects as per protocol; assist in accurate data collection, and ordering all protocol requirements and obtaining results
- Preparation, collection, and shipment of all required protocol specimens
- Travel to other sites as needed for research activity/patient coverage
- Attend National Research meetings as needed
++NOTE: This job is in adult oncology. Home base will be Fresno++
Qualifications:
Basic Qualifications:
- 2 years of recent clinical nursing experience in a hospital, clinic or similar health care setting required. (Bachelor's degree may be substituted for 1 year work experience.)
- Clinical trials research experience preferred.
- Minimum of a diploma from an accredited nursing school required.
- Valid RN license from the State of California
- Must be proficient in electronic health systems & databases used in research environment, or willingness to learn & demonstrate proficiency within six months of hire.
- Demonstrate effective written, verbal, & interpersonal communication skills.
- Attention to detail & accuracy.
- Ability to manage multiple tasks w/ time deadlines.
- Demonstrate prioritization & organizational skills.
- Proficient in medical terminology.
- Demonstrate basic drug calculation skills.
- Demonstrate problem-solving skills.
- Demonstrate nursing competency skills per scope of practice (i.e., phlebotomy, performing vital signs, nursing assessments, urine dipstick reading, pregnancy test reading, performing EKG, etc.) w/ certification if applicable.
- Other (specific to relevant therapeutic area).
- Knowledge of GCP, federal, state, & local regulations including HIPAA & KP policies & procedures.
- Ability to work in a Labor Partnership environment.
Preferred Qualifications:
- Minimum of 2-3 years experience as a RN with 1 of the last 2-3 years in oncology. Oncology -certified nurse a plus.
- Previous research experience desirable but not required. Phlebotomy skills a plus.
- Ability to make and complete accurate patient assessments.
- Demonstrated ability to work independently and cooperatively in multiple settings.
- Exhibited ability to set priorities and meet goals. Must have excellent verbal and written communication skills.
- Excellent documentation skills. Must be flexible, organized, detail oriented and tenacious in follow-through.
- Ability to work well under pressure.
- Computer skills in WORD, Excell and internet preferred.
-Willing to abide by Good Clinical Practice Guidelines and all FDA regulations. CPR-certified
++NOTE: Must be willing and able to travel within the Northern California region with own dependable transportation ++
Submit Now Click here for additonal requirements