Clinical Trial Research Nurse Manager
Company: Kaiser
Location: Vallejo
Posted on: May 3, 2024
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 skills
- Ability to work independently
- Ability to work on teams, and assigned committees
- Ability to work in a designated management structure
- Ability to work in a Labor Partnership environment
- Must 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 AdditionHoursPerWeek :
40Shift : DayWorkdays : Mon - FriWorkingHoursStart : 08:30
AMWorkingHoursEnd : 05:00 PMJob Schedule : Full-timeJob Type :
StandardEmployee Status : RegularEmployee Group/Union Affiliation :
NUE-NCAL-09 NUE Non Union EmployeeJob Level : Manager with Direct
ReportsJob Category : Nursing Licensed & Nurse
PractitionersDepartment : Oakland Reg - 2000 Broadway -
Rsrch-Invstgtr Staffg Mdl Dept - 0201Travel : Yes, 25 % of the
TimeKaiser 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.
Keywords: Kaiser, Petaluma , Clinical Trial Research Nurse Manager, Healthcare , Vallejo, California
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