Clinical Trial Research Nurse I

The Clinical Trial Nurse I (CTN-I) is a novice level position which, under the guidance & supervision of the Principal Investigator (PI) & clinical trials admin Mgmt, assists in ensuring that the integrity & quality of the clinical trial(s) are maintained & conducted in accordance w/Fed, state & local regulations, Institutional Review Board (IRB) approvals, & 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:

* Compliance: Support & comply w/the Principles of Responsibility (KP Code of Conduct). W/ guidance from PI, assist w/ ensuring compliance w/KPNC IRB approved protocols.

* Adhere to Guideline for 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.

* Study Implementation: W/guidance from PI, utilize nursing skills to coordinate research-related activities (e.g., 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 & averse events to the PI in a timely manner to ensure the health, safety & welfare of the participants.

* W/ supervision, utilize & Doc the nursing procedures to plan, deliver, & evaluate research care for non-complex medical conditions &, w/appropriate assistance, for complex medical conditions.

* W/supervision & direction by PI &/or designee, plan recruitment procedures for potential participants.

* Assist in the determination of eligibility of candidates for study participation.

* Assist in the identification & procurement of equipment & supplies needed to fulfill protocol requirements.

* W/supervision, assist in the enrollment of subjects into the trial (screening, randomization, data collection) & any study-related procedures as required by protocol.

* W/direction from PI, continuously assess participants to ensure continued eligibility for participation in the study.

* Participate in the ongoing informed consent process w/the PI to ensure that research participants & their families have their questions answered & understand the patient/participant Bill of Rights, consent form, & participant's responsibilities in the study.

* W/direction, communicate w/participants throughout the study regarding pertinent updated study info.

* Accurately & completely record info in source Docs in a timely manner.

* W/ supervision, assist in the accurate & appropriate study test article management.

* Coordinate & perform packaging & shipping of protocol specimens to the Sponsor lab in accordance w/ IATA/DOT regulations & * Sponsor shipping guidelines, if applicable.

* W/in the nursing scope of practice, assist the PI w/the care & evaluation of research participants.

* W/direction, 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.

* Support the regulatory team in the maintenance & storage of critical Docs required to be maintained & provided to the Sponsor during the conduct of the trial.

* Support the effective financial management of the clinical trial.

* This job description is not all encompassing.

Basic Qualifications:

Experience

* Minimum two (2) years of clinical nursing experience in a hospital, clinic or similar health care setting within the last three (3) years required (Bachelor's degree may be substituted for one (1) year work experience).

Education

* Minimum of a diploma from an accredited nursing school required.

* High School Diploma or General Education Development (GED) required.

License, Certification, Registration

* N/A

Additional Requirements:

* Must be proficient in electronic health systems and databases used in research environment, or willingness to learn and demonstrate proficiency within six months of hire.

* Demonstrate effective written, verbal, and interpersonal communication skills.

* Attention to detail and accuracy.

* Ability to manage multiple tasks with time deadlines.

* Demonstrate prioritization and 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.) with certification if applicable.

* Other (specific to relevant therapeutic area).

* Knowledge of GCP, federal, state, and local regulations including HIPAA and KP policies and procedures.

* Must be able to work in a Labor/Management Partnership environment.

Preferred Qualifications:

* Clinical trials research experience preferred.