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 IILocation: Oakland, CA Additional Locations:
Job Number: 854453 Date posted: 01/14/2020
- Compliance Support & comply w/the Principles of Responsibility (KP Code of Conduct). W/guidance from PI, ensure 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, prepare for inspections, audits & monitor visits.
- Study Implementation Maintain the security & confidentiality of participants' paper or electronic data (e.g., case report forms kept in a secure, locked space). Direct issues requiring medical decision-making to the appropriate licensed staff member promptly. According to protocol &/or IRB-approved telephone script, collect & document research data & report the information to the appropriate licensed staff member & PI for assessment in a timely manner. Coordinate & schedule participants for study assessments/visits, required tests, including visit specific lab kits &/or paperwork preparation, etc. Prepare packets for participants (e.g., instructions, phone numbers, calendars, diaries, etc.). W/appropriate guidance, obtain & review medical records & test results of all project/study participants & abstract needed data per protocol requirements. W/guidance from PI, complete case report forms (paper or electronic) & maintain a database program to track all study activity including study enrollment & consents. Respond to Sponsor to resolve data queries & delinquencies in a timely manner. Report any potential protocol violations/deviations to the PI in a timely manner. 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). Coordinate & prepare protocol specimens for shipping or storage in accordance w/ IATA/DOT regulations & Sponsor shipping guidelines. Assist w/ participant's long-term follow-up data collection. Assist PI &/or Clinical Trial Nurse, if applicable, w/ identifying, screening, & recruiting potential participants. Provide PI &/or Clinical Trial Nurse w/ the ongoing informed consent process by coordinating the current consent documents. Assist in study closure activities including preparation & collection of close-out documentation, & preparation of study files for distribution to longterm storage. W/guidance, receive, disseminate & maintain study-related communications w/ internal & external parties involved w/clinical trial protocols.
- This job description is not all encompassing.
- One (1) year of experience in clinical trials research OR a bachelor's degree required.
- Bachelor's degree may be substituted for 1 year work experience.
- Associates 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.
- Current BLS certification required prior to start date.
- Satisfies requirements for career advancement as defined by the Clinical Trial Career Ladder Program.
- Must be proficient in electronic health systems and data bases used in research environment and word-processing and database software 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.
- Attention to detail and accuracy.
- Ability to manage multiple tasks Demonstrate prioritization skills.
- Demonstrate problem-solving skills.
- Demonstrate project management skills.
- Ability to be flexible and dependable.
- Possess ability to work effectively on cross-functional teams.
- Present professional manner and appearance.
- Possess ability to abstract pertinent protocol data from medical record.
- Skill in administrative tasks (i.e., filing, photocopying, faxing, etc.).
- Knowledge of the principles, methods and procedures of basic medical and/or clinical research processes.
- Knowledge and understanding of human research protection regulations, policies, procedures, and standards as applied to IRB and compliance operations.
- Knowledge of clinical trials research and research regulations, as well as clinical trial experience in a specific 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 Partnership environment.
- Current ACRP or SoCRA certification 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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