APP Office of Clinical Research

3 weeks ago

San Francisco, United States Kaiser Permanente Full time
Job Summary:
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 positions 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.
Essential Responsibilities:

  • Compliance Support and comply with the Principles of Responsibility (Kaiser Permanente Code of Conduct). With guidance from PI, assist with ensuring compliance with KPNC IRB Standard Operating Procedures (SOP) and document applications. Adhere to Guideline for Good Clinical Practice (GCP), federal, state, and local regulations, and KP policies and procedures. With supervision, assist with preparation for inspections, audits and monitoring visits.
  • Study Implementation Maintain the security and confidentiality of participants paper or electronic data (e.g., case report forms kept in a secure, locked space). Assist with 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 with obtaining medical records and test results for all projects/participants. ith supervision and certification, perform packaging and shipping of protocol specimens to the Sponsor lab in accordance with IATA/DOT regulations and Sponsor shipping guidelines. Direct issues requiring medical decision-making to the appropriate licensed staff member promptly.
  • Provide PI and/or Clinical Trial Nurse with the ongoing informed consent process by coordinating the current consent documents. According to protocol and/or IRB-approved telephone script, collect and document research data in a timely manner, and report the information to the appropriate licensed staff member and PI for assessment. Assist in the collection of protocol-required data with timely and accurate submissions as required by Sponsor (e.g., weekly screening log, routine electronic data submissions).
  • Under specific direction, assist with data entry of study activity onto a case report form (paper or electronic), and maintain a database program to track all study activity (i.e., study enrollment and consents). Assist in maintaining research charts and site regulatory files. Assist in ensuring that study-related, non-test article supplies are shipped and re-supplied according to protocol, including tracking expiration dates. Assist in obtaining protocol specific regulatory documents including MDs/RNs licenses and CVs.
  • Report any potential protocol violations/deviations to the PI in a timely manner. Support the regulatory team in the maintenance and storage of critical documents required to be maintained and provided to the Sponsor during the conduct of the trial. With supervision, assist in study closure activities including preparation and collection of close-out documentation, and preparation of study files for distribution to long-term storage.
  • Leadership and Communication With direction, communicate compliance and operational needs with internal and external parties, PI, KPNC Clinical Trials Operations Leader or designee, and KPNC Office(s) of Clinical Trial Compliance on an ongoing basis. If applicable and with supervision, coordinate IRB communications (e.g., new protocols, amendments, continuing review applications, protocol violations, and adverse events) in accordance with departmental and KP policies and procedures.
  • Education and Training With direction, participate in training, education, and development activities to improve own knowledge and performance to sustain and enhance professional development. Work with an assigned mentor on a regular basis for training and resource questions. Attend KP site-initiated meetings for protocol training including Sponsor-initiated meetings, as requested. Participate as a member of the Clinical Trial Operations Team (CTOT) and attend meetings as requested.
  • Quality Improvement With direction, perform routine quality control activities and assist with quality improvement initiatives.
  • Systems and Infrastructure Adhere to departmental policies and procedures to ensure confidentiality, privacy and security of clinical research interactions and participant information, and responsible use of operational research databases in compliance with KP policies. Adhere to departmental policies and procedures to support quality implementation and conduct of clinical trials, and assure maintenance of research documentation in compliance with the protocols and KP policies and procedures. Maintain systems and resources to effectively communicate with and obtain required IRB documentation.
  • Staff Supervision No supervisory responsibilities.
  • General Perform job functions according to the factors listed below under Job Criteria. Other duties as assigned by appropriate management.
  • 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

  • N/A

Education

  • Associates degree or higher OR 2 years of work experience in an ambulatory and/or acute health care setting required (LVN maybe substituted for an Associates degree)
  • High School Diploma or General Education Development (GED) required.

License, Certification, Registration

  • N/A

Additional Requirements:

  • Clinical Research Assistant

    2 months ago

    San Antonio, United States Pinnacle Clinical Research Full time

    Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient...

  • Clinical Research Assistant

    2 months ago

    San Antonio, United States Pinnacle Clinical Research Full time

    Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient...

  • Clinical Research Assistant

    3 weeks ago

    San Antonio, United States Pinnacle Clinical Research Full time

    Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient...

  • Clinical Research Principal Investigator

    2 weeks ago

    San Bernardino, United States American Clinical Research Services Full time

    Catalina Research Institute (CRI), an ACRS company is located in Montclair, CA and they focus on Phase I-III clinical trials in complex metabolic and central nervous system indications. We are seeking a Clinical Research Principal Investigator. Part time role: 10 - 20 hours per weekFull time role: 30 - 40 hours per weekThe successful candidate must be one of...

  • Clinical Research Principal Investigator

    2 weeks ago

    san bernardino, United States American Clinical Research Services Full time

    Catalina Research Institute (CRI), an ACRS company is located in Montclair, CA and they focus on Phase I-III clinical trials in complex metabolic and central nervous system indications. We are seeking a Clinical Research Principal Investigator. Part time role: 10 - 20 hours per weekFull time role: 30 - 40 hours per weekThe successful candidate must be one of...

  • Clinical Research Principal Investigator

    2 weeks ago

    San Bernardino, United States American Clinical Research Services Full time

    Catalina Research Institute (CRI), an ACRS company is located in Montclair, CA and they focus on Phase I-III clinical trials in complex metabolic and central nervous system indications. We are seeking a Clinical Research Principal Investigator. Part time role: 10 - 20 hours per weekFull time role: 30 - 40 hours per weekThe successful candidate must be one of...

  • Clinical Research Coordinator I

    4 weeks ago

    San Diego, United States Headlands Research Full time

    Overview Artemis Research is a leading principal investigator- and patient-focused clinical research company dedicated to advancing medical treatments. Established in 2008 by colleagues who bring more than 50 years of combined research experience, Artemis specializes in Psychiatry/Neurology, Internal Medicine, and Women's Health studies. With multiple...

  • Medical Research Assistant

    1 week ago

    San Antonio, Texas, United States Pinnacle Clinical Research Full time

    Pinnacle Clinical Research is a pioneering medical research organization dedicated to advancing healthcare through innovative clinical studies. As a Medical Research Assistant - Fibroscan Expert, you will play a vital role in contributing to our mission.About the RoleThis exciting opportunity is available for an experienced Fibroscan expert who can provide...

  • Medical Imaging Specialist

    10 hours ago

    San Antonio, Texas, United States Pinnacle Clinical Research Full time

    Job DescriptionThis is a medical imaging specialist position at Pinnacle Clinical Research, where we are committed to driving innovation and advancing medical knowledge through rigorous research studies.ResponsibilitiesWe are seeking a highly skilled professional to perform Fibroscans on patients as needed and maintain subject and study confidentiality.The...

  • Clinical Research Coordinator 2

    2 weeks ago

    san antonio, United States Worldwide Clinical Trials Full time

    Who we areWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...

  • Clinical Research Coordinator 2

    2 weeks ago

    San Antonio, United States Worldwide Clinical Trials Full time

    Who we areWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...

  • Clinical Research Coordinator 2

    2 weeks ago

    San Antonio, United States Worldwide Clinical Trials Full time

    Who we areWorldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications – from discovery to reality. Anchored in our company’s scientific heritage, our dedicated therapeutic focus on...

  • Valuation Specialist, Applied Research Center

    2 weeks ago

    San Francisco, United States Cornerstone Research Full time

    Valuation Specialist, Applied Research CenterJob LocationsUSID2024-3693CategoryAssociateOverviewWho We AreCornerstone Research provides economic and financial consulting and expert testimony in all phases of complex disputes and regulatory investigations. The firm works with an extensive network of prominent academics and industry practitioners to identify...

  • Budgets and Contracts Specialist

    2 months ago

    San Antonio, United States Pinnacle Clinical Research Full time

    Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient...

  • Clinical Research Associate

    3 days ago

    San Francisco, United States UCSF Benioff Children's Hospital Full time

    Uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies / procedures to apply federal, state, and university regulations, policies, and guidelines, and promote Clinical Research, Research Associate, Clinical, Associate, Research, Healthcare

  • Accounts Receivable Clerk

    1 month ago

    San Antonio, United States Pinnacle Clinical Research Full time

    Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient...

  • Administrative Assistant III

    4 weeks ago

    San Antonio, United States DM Clinical Research Full time

    Administrative Assistant III This position works in tandem with our clinical research staff and multiple other departments to provide excellent customer care to patients participating in our clinical research trials while overseeing Administrative Assistant workflows, monetary transactions, and managing safe storage of gift cards and payments.DUTIES &...

  • Accounts Receivable Specialist

    1 month ago

    San Antonio, Texas, United States Pinnacle Clinical Research Full time

    Accounts Receivable SpecialistPinnacle Clinical Research is seeking a highly skilled Accounts Receivable Specialist to join our team. As an Accounts Receivable Specialist, you will be responsible for managing the day-to-day accounts receivable function, with a focus on collections and supporting our departments and business operations.Key...

  • Clinical Research Coordinator

    3 days ago

    San Francisco, United States Taxa Full time

    A Bit About Us:From mosquito repellents to deodorants, Taxa is building single-application long duration skincare products, with performance measured in weeks, not hours. We aim to accomplish this by genetically engineering skin microbial species, and steering these communities away from performing undesirable metabolic functions.The Opportunity:We are...

  • Revenue Cycle Specialist

    3 weeks ago

    San Antonio, Texas, United States Pinnacle Clinical Research Full time

    About the RolePinnacle Clinical Research is seeking an experienced Accounts Receivable Clerk to join our team. As a key member of our financial operations, you will be responsible for managing the day-to-day accounts receivable function, with a focus on collections and supporting our departments and business operations.Key ResponsibilitiesMonitor and...