Innovation in Practice
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 Trial Research Coordinator ILocation: Santa Clara, CA Additional Locations:
Job Number: 813472 Date posted: 08/07/2019
- 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 & CVs.
- 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.
responsibilities are to provide data management in a timely manner for patients
on cancer trials including facilitating patient entry into programs and
managing and collecting data for submission to research centers.
- Will manage
all screening, active treatment and follow up data form submissions, xrays, and
pathology specimens for all protocols patients.
assist in the oncologists- in ordering/scheduling specific protocol
tests/appointments as directed by physician or research nurse.
require travel by own reliable transportation to different centers and
interactions with pharmacists, oncologists- surgeons, oncology nurses and
patients to assist in patient enrollment and adherence to all research
IRB regulatory material at the local site level.
adverse event/serious adverse event submissions to the IRB and sponsors.
- 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) required.
License, Certification, Registration
- Willingness to obtain IATA/DOT certification prior to start date.
- 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 skills.
- 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.
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.
About Research & Development Careers
Careers in Research & Development
Recognized worldwide for their scientific expertise, our researchers collect data on topics including cardiovascular disease, diabetes, mental health, and drug safety — just to name a few.
In addition to studies centered at these facilities, our physicians and researchers conduct clinical trials of new drugs, medical devices, and other therapies through several organized centers and independently at single sites. Put together, Kaiser Permanente's research centers and scientists comprise one of the largest and most comprehensive nonacademic research programs in the United States.
As a member of this team, you'll engage in meaningful work that has the power to affect outcomes and improve global health. Focused on areas like public-sector health services, epidemiology, and behavioral and clinical research, the work you do will ultimately allow us to improve the cost effectiveness and quality of the care we deliver — all while saving lives.
See What People are Saying About Working at KP
Mar 26, 2019
"The best job I have ever had!"
- Positive Outlook
- Approves of CEO
I have been working at Kaiser Permanente full-time for more than a year
Real focus on creating higher quality, more affordable healthcare. Talented coworkers and great mentors. Fabulous benefits.Full Review
Come introduce yourself to a member of the Kaiser Permanente team at an upcoming career or professional event. We look forward to meeting you in person.
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