Clinical Trials Research Coordinator I - Santa Clara
Company: Kaiser Permanente
Location: Santa Clara
Posted on: February 22, 2021
Important Update: In response to the COVID-19 pandemic, Kaiser
Permanente is moving to a virtual recruitment process including
telephone and video interviews to help ensure the health and safety
of our employees, candidates, and communities. Also, some hiring
activities may be delayed or suspended in certain geographic areas
and job categories. For more information on Kaiser Permanente's
response to COVID-19, visit our Resource Center . Operating one of
the industry's largest and most respected research programs, Kaiser
Permanente employs nearly 1,800 research experts at 9 specialized
centers across the country. With a research budget of $221 million
and more than 2,500 studies and clinical trials underway at any
given time, this is a place where you can have a profound impact on
the future of health. Clinical Trials Research Coordinator I -
Santa Clara Description: The Clinical Trial Research Coordinator I
(CTRC-I) is a novice level position which, under the clinical
direction of the Principal Investigator (PI), assists in the
operational and administrative research support of the Kaiser
Permanente Northern California (KPNC) PI and KPNC Clinical Trials
Operations Director or designee, and other research staff
conducting multiple FDA-regulated clinical trials. This is a
non-licensed position which works under the daily supervision of an
experienced Clinical Trial Nurse, Clinical Trial Research
Coordinator, and/or KFRI-designated, licensed clinical trial
research staff member. This position must adhere to the position's
scope of practice as outlined in the Major Responsibilities below.
This position is also responsible for assisting in protecting the
health, safety, and welfare of research participants.
- ComplianceSupport & comply w/ the Principles of Responsibility
(Kaiser Permanente Code of Conduct). W/ guidance from PI, assist w/
ensuring compliance w/ KPNC IRB Standard Operating Procedures (SOP)
& document applications. Adhere to Guideline for Good Clinical
Practice (GCP), federal, state, & local regulations, & KP policies
& procedures. W/ supervision, assist w/ preparation for
inspections, audits & monitoring visits.
- Study Implementation:--Maintain the security & confidentiality of
participants' paper or electronic data (e.g., case report forms
kept in a secure, locked space). Assist w/ scheduling participants
for study assessments/visits, required tests including
visit-specific laboratory kits and/or paperwork preparation.
Prepare packets for participants (e.g., instructions, phone
numbers, calendars, diaries, etc.).
- Assist w/ obtaining medical records & test results for all
projects/participants. w/ supervision & certification, perform
packaging & shipping of protocol specimens to the Sponsor lab in
accordance w/ IATA/DOT regulations & Sponsor shipping guidelines.
Direct issues requiring medical decision-making to the appropriate
licensed staff member promptly.
- Provide PI and/or Clinical Trial Nurse w/ the ongoing informed
consent process by coordinating the current consent documents.
According to protocol and/or IRB-approved telephone script, collect
& document research data in a timely manner, & report the
information to the appropriate licensed staff member & PI for
assessment. Assist in the collection of protocol-required data w/
timely & accurate submissions as required by Sponsor (e.g., weekly
screening log, routine electronic data submissions).
- Under specific direction, assist w/ data entry of study activity
onto a case report form (paper or electronic), & maintain a
database program to track all study activity (i.e., study
enrollment & consents). Assist in maintaining research charts &
site regulatory files. Assist in ensuring that study-related,
non-test article supplies are shipped & re-supplied according to
protocol, including tracking expiration dates. Assist in obtaining
protocol specific regulatory documents including MDs/RNs licenses &
- Report any potential protocol violations/deviations to the PI in
a timely manner. Support the regulatory team in the maintenance &
storage of critical documents required to be maintained & provided
to the Sponsor during the conduct of the trial. W/ supervision,
assist in study closure activities including preparation &
collection of close-out documentation, & preparation of study files
for distribution to longterm storage.
- This job description is not all encompassing. Basic
- Associate's degree or higher OR two (2) years of work experience
in an ambulatory and/or acute health care setting required (LVN
maybe substituted for an Associate's degree)
- High School Diploma or General Education Development (GED)
License, Certification, Registration
- Willingness to obtain IATA/DOT certification prior to start
- Current BLS certification required prior to start date.
- Satisfies requirements for career advancement/maintenance as
defined by the Clinical Trial Career Ladder Program.
- Must be proficient in electronic health systems and databases
used in research environment and word-processing or willingness to
learn within 3 months of hire.
- Demonstrate organizational and communication skills.
- Demonstrate written, verbal, and interpersonal communication
- Demonstrate proficiency in medical terminology.
- Demonstrate attention to detail and accuracy.
- Ability to manage multiple tasks.
- Demonstrate good prioritization and organizational skills.
- Ability to be flexible and dependable.
- Ability to work effectively on cross-functional teams.
- Present professional manner and appearance.
- Demonstrated skill in administrative tasks (i.e., filing,
photocopying, faxing, etc.).
- Knowledge of GCP, federal, state, and local regulations including
HIPAA and KP policies and procedures.
- Must be able to work in a Labor Partnership environment.
- Clinical trials experience preferred. Primary Location:
California,Santa Clara,Santa Clara Hospital Scheduled Weekly Hours:
40 Shift: Day Workdays: Mon - Fri Working Hours Start: 8:30 AM
Working Hours End: 5:00 PM Job Schedule: Full-time Job Type:
Standard Employee Status: Regular Employee Group/Union Affiliation:
NUE-NCAL-09-NUE-Non Union Employee Job Level: Entry Level Job
Category: Research and Development Department: Div of Research
Travel: Yes, 5 % 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.
External hires must pass a background check/drug screen. Qualified
applicants with arrest and/or conviction records will be considered
for employment in a manner consistent with federal and state laws,
as well as applicable local ordinances, including but not limited
to the San Francisco and Los Angeles Fair Chance Ordinances.
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