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:
Coordinate and manage assigned clinical trials in collaboration with Principal Investigator (PI) and Sub-PI in clinical trials unit; complete case report forms; correct case report forms and respond to data queries; collect and process research study specimens per protocol; update and maintain all essential regulatory documents; report and document safety data to sponsor and IRB per protocol and SOP requirements; maintain accurate and updated research databases and/or tracking systems; prepare and submit reports as required by sponsor or IRB; oversee functions of clinical research assistant; administer clinical trial drugs; throroughly and accurately document all clinical trial communications and interventions with attention to detail; schedule and conduct subject follow-up visits; recognize and report study safety occurrences such as serious adverse events, death, and unanticipated adverse events to IRB and sponsor per sponsor and SOP requirements; work collaboratively and closely with the Principal Investigators and study principals to ensure Good Clinical Practice Compliance and compliance with KP SOPs. Excellent teamplayer and multitasker; must have high level of autonomy and discretion; process-oriented and effective problem-solver with good attention to details and follow up.
Qualifications:
Basic Qualifications:
- Two (2) years of recent clinical nursing experience in a hospital, clinic or similar health care setting required. (Bachelor's degree may be substituted for one (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:
- BSN or MSN.
- ACLS, CCRP or CCRC certifications.
- Industry experience, QA or regulatory affairs experience.
- Staff or project management experience a plus.
- Strong Medical/Surgical Nursing, ICU stepdown, ICU/CCU or emergency department experience.
- Clinical research coordinator experience highly desirable,
- Experience in cardiology therapeutic area and/or clinical trials, knowledge of Good Clinical Practice and Quality Management a plus.
- Current skills in IV therapy, drug calculation and administration a plus but not required.
- Proficient with computer operations using Word, Excel, Outlook, and Powerpoint.
- Excellent organizational, writing and presentation skills.
External hires must pass a background check/drug screen.
We are proud to be an equal opportunity/affirmative action employer.