Clinical Trial Research Nurse Manager
Company: Kaiser
Location: El Sobrante
Posted on: April 17, 2024
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Job Description:
Job Summary:
The Clinical Trial Nurse Manager (CTN-Manager) position assists in
the administrative leadership and direction of the operational
aspects of a large and/or multiple regional clinical trials
program. This position oversees clinical trial research activities
of non-physician research personnel in a manner that effectively
maximizes quality and compliance with clinical research standards,
participant safety, and staff satisfaction.
Essential Responsibilities:
Assists in the daily operations of research units at multiple
locations.
Under the direction of clinical trials administrative management,
interprets policies and implement procedures for the program,
ensure compliance with KP HealthPlan and governmental agencies.
Prepares for audits and inspections by internal and external
auditors, including coordination of the development of corrective
action plans and follow-up
Provide support during internal and external audits. Assure audit
readiness.
Collaborates with PI and Sponsor in establishing, implementing, and
conducting clinical trials
Develop budgets
Evaluate potential protocols to determine feasibility, resource
requirements, etc.
Establishes and maintains effective partnerships to ensure
region-wide communication and coordination of the clinical trials
program, fostering teamwork
Serve as a mentor and content expert to research staff.
Resolve complex operational and personnel issues.
Assists licensed and non-licensed research staff to effectively
maximizes quality and compliance with clinical research standards,
participant safety, and staff and member satisfaction.
Identify training needs, develop materials and coordinate
training.
Collaboratively develops strategies and implement protocol-specific
operating procedures to improve the quality of research and patient
care.
Assist in developing and implementing departmental policies and
procedures.
Assist in development of clinical trials technology systems and
infrastructure.
Recruits and hires new clinical research staff.
Effectively manage staff, budget, resource/allocation planning, and
performance assessments for a variety of clinical, regulatory and
research functions.
Kaiser Permanente conducts compensation reviews of positions on a
routine basis. At any time, Kaiser Permanente reserves the right to
reevaluate and change job descriptions, or to change such positions
from salaried to hourly pay status. Such changes are generally
implemented only after notice is given to affected employees.
Basic Qualifications:
Experience
Minimum five (5) years of clinical nursing experience in a
hospital, clinic or similar health care setting required.
Minimum three (3) years of supervisory experience in a hospital,
clinic or similar setting required.
Education
Diploma from an accredited nursing school required.High School
Diploma or General Education Development (GED) required.
License, Certification, Registration
Registered Nurse License (California)
Basic Life Support
Additional Requirements:
Experience in outpatient and/or inpatient clinical environment,
clinical trial regulatory and data submission requirements.Ability
to analyze research protocols and KP and KFRI policies and
procedures with respect to implementation and medical, nursing,
fiscal, compliance, quality, and risk management aspects. In-depth
working knowledge of nurse practice act, GCP, federal, state, and
local regulations including HIPAA and KP policies and
procedures.Knowledge of and experience in outpatient and/or
inpatient clinical environment, clinical trial regulatory and data
submission requirements.Effective written oral and written
communications skillsAbility to work independentlyAbility to work
on teams, and assigned committeesAbility to work in a designated
management structureAbility to work in a Labor Partnership
environmentMust be able to work in a Labor/Management Partnership
environment.Certification in one or more therapeutic areas
required.Willingness to obtain other certifications, if
required.
Preferred Qualifications:
Minimum three (3) years of clinical trials research experience
preferred.Minimum four (4) years of effective project management,
analytical problem solving and negotiating experience.Current
IATA/DOT certification preferred.Bachelors degree preferred.
PrimaryLocation : California,Vallejo,Vallejo Medical Offices
Addition
HoursPerWeek : 40
Shift : Day
Workdays : Mon - Fri
WorkingHoursStart : 08:30 AM
WorkingHoursEnd : 05:00 PM
Job Schedule : Full-time
Job Type : Standard
Employee Status : Regular
Employee Group/Union Affiliation : NUE-NCAL-09-NUE-Non Union
Employee
Job Level : Manager with Direct Reports
Job Category : Nursing Licensed & Nurse Practitioners
Department : Oakland Reg - 2000 Broadway - Rsrch-Invstgtr Staffg
Mdl Dept - 0201
Travel : Yes, 25 % of the Time
Kaiser Permanente is an equal opportunity employer committed to a
diverse and inclusive workforce. Applicants will receive
consideration for employment without regard to race, color,
religion, sex (including pregnancy), age, sexual orientation,
national origin, marital status, parental status, ancestry,
disability, gender identity, veteran status, genetic information,
other distinguishing characteristics of diversity and inclusion, or
any other protected status.--s-p-m1--
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Keywords: Kaiser, San Francisco , Clinical Trial Research Nurse Manager, Healthcare , El Sobrante, California
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