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Experience:
No experience
Employment Type:
Intern/Co-op
Posted:
9/7/2015
Job Category:
Other
Industry:
Health Care & Medicine
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Clinical Trials Research Nurse I
Kaiser Permanente | Redwood City, California
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Job Description

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.Must be willing and able to travel within the Northern California region with own dependable transportation. This job is in adult oncology. Home base will be Redwood City.  Willing to abide by Good Clinical Practice Guidelines and all FDA regulations.

 

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.

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.Must be willing and able to travel within the Northern California region with own dependable transportation. This job is in adult oncology. Home base will be Redwood City.  Willing to abide by Good Clinical Practice Guidelines and all FDA regulations.

 

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.

Qualifications

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:

Minimum of 2-3 years experience as a RN with 1 of the last 2-3 years in oncology required.
Demonstrated ability to work independently and cooperatively in multiple settings. 
Exhibited ability to set priorities and meet goals.
Must have excellent documentation skills.
Must be flexible, organized, detail oriented and tenacious in follow-through.
Must possess the ability to work well under pressure.
CPR-certified required.

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.

Oncology certified nurse preferred.
Previous research experience desirable but not required. 
Phlebotomy skills a plus. 
Computer skills in WORD, Excel and internet preferred.

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:

Minimum of 2-3 years experience as a RN with 1 of the last 2-3 years in oncology required.
Demonstrated ability to work independently and cooperatively in multiple settings. 
Exhibited ability to set priorities and meet goals.
Must have excellent documentation skills.
Must be flexible, organized, detail oriented and tenacious in follow-through.
Must possess the ability to work well under pressure.
CPR-certified required.

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.

Oncology certified nurse preferred.
Previous research experience desirable but not required. 
Phlebotomy skills a plus. 
Computer skills in WORD, Excel and internet preferred.

About Kaiser Permanente

Company Description

Serving approximately 8.7 million members in nine states and the District of Columbia, Kaiser Permanente is America's leading nonprofit integrated health plan.

Kaiser Permanente's mission is to provide high-quality, affordable health care services to improve the health of our members and the communities we serve.

Our Northern California Region provides integrated health care services to approximately 3.2 million members. Approximately 4,400 physicians of The Permanente Medical Group provide services at 20 medical centers and numerous medical offices.

Company History

Founded in 1945, Kaiser Permanente is the nation’s largest not-for-profit health plan, serving more than 8.6 million members, with headquarters in Oakland, Calif. It comprises:

  1.   • Kaiser Foundation Health Plan, Inc.

  • Kaiser Foundation Hospitals and their subsidiaries

  • The Permanente Medical Groups.

At Kaiser Permanente, physicians are responsible for medical decisions. The Permanente Medical Groups, which provide care for Kaiser Permanente members, continuously develop and refine medical practices to help ensure that care is delivered in the most efficient and effective manner possible.

Kaiser Permanente’s creation resulted from the challenge of providing Americans medical care during the Great Depression and World War II, when most people could not afford to go to a doctor. Among the innovations it has brought to U.S. health care are:

  • prepaid health plans, which spread the cost to make it more affordable

  • physician group practice to maximize their abilities to care for patients

  • a focus on preventing illness as much as on caring for the sick

  • an organized delivery system, putting as many services as possible under one roof

Mission & Values

As a health care organization in the 21st century, we have a mission--to provide quality care for our members and their families, and to contribute to the well-being of our communities.

Working Here

When you bring your career to Kaiser Permanente, the work you do directly affects the health of millions. From the business people who shape our policies, to the IT professionals enabling life-saving data, to the nurses and physicians on the front line of patient care, everyone here has a role to play in the care continuum. Knowing you have a place in that process and witnessing the outcome of the work you do is empowering. It gives you a cause to stand behind. And it makes you feel proud of the work you do every day. When people witness the impact of their contributions, they excel. Together we have the power to make a difference.

Hiring Information

The first step in beginning your career search is to look for open jobs that match your skills, qualifications, and interests. Each posting includes a description of the position and the minimum required qualifications. Once you find a position you are interested in, register for an account and provide your information for consideration online.

Benefits

As an employee, you are eligible for benefits according to your full-time/part-time status and the number of hours scheduled to work per week. Benefits may vary based on your Kaiser Permanente region, position, scheduled hours, and representation by collective bargaining or employee groups, but generally include:

  • generous vacation, holiday, and sick leave

  • medical care (including prescriptions), vision, mental health, and dental care

  • disability and life insurance coverage

  • educational opportunities and tuition reimbursement

  • employee assistance programs

  • health care, dependent care, and transit spending account options

  • retirement plans

In addition, we believe in recognizing stellar performance and sponsor a variety of programs designed to reward our skilled, innovative, caring, and committed staff.

In short, at Kaiser Permanente, we understand that there is a direct correlation between happy employees and happy members. We take pride in the compassion and dedication of our employees and find many ways to reward their hard work. In return, our employees take pride in being a part of a collaborative, professional team focused on quality, service, and care.

Honors & Awards

Kaiser Permanente of Northern California has earned an "Excellent" rating from the National Committee for Quality Assurance (NCQA)-the nation's leading reviewer of health plan quality for consumers and employers. Excellent is the top rating granted by NCQA, which reviews satisfaction surveys, preventive measures, physician credentialing, member services and improvement initiatives.*

Both our Northern and Southern California regions were the only health plans in California identified by the NCQA in its list of the best health care programs in the Pacific States. (NCQA's The State of Health Care Quality 2003)

The Joint Commission on Accreditation of Healthcare Organizations accredits all Kaiser Foundation Hospitals in California.

For the seventh straight year, no other health plan has earned higher ratings from the California Cooperative Health Reporting Initiative on more measures than Kaiser Permanente. The annual ratings measure clinical quality and member satisfaction. (CCHRI Report on Quality 2003)

Our Northern California region received more three-star "Excellent" ratings than any other health plan surveyed by California's Office of the Patient Advocate on California's Quality of Care Report Card 2003-04.

* Commercial HMO and Medicare-contracted product lines: April 2003.