Clinical Research Associate jobs in California

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Clinical Research Associate II
  • Advanced Clinical
  • Alameda, CA FULL_TIME
  • OVERVIEW
    We are currently searching for a skilled professional to join a well-known client's team as a Clinical Research Associate II in Alameda, CA. The Clinical Research Associate II will assist in the clinical execution and management of all aspects of assigned clinical studies. This includes but not limited to planning and implementation of clinical studies from concept to clinical study report per timelines and quality standards. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.


    RESPONSIBILITIES
    The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
    * Conduct single or multi-center medical device clinical studies.
    * Perform study site visits (SQV, SIV, IMV, COV), generate monitoring trip reports, and track resolution of action items.
    * Participate in study start up activities.
    * Responsible for shipping study devices and supplies to clinical sites and performing study device accountability.
    * Manage clinical monitoring activities and overall site management ensuring compliance to the Study Protocol, Good Clinical Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements.
    * Responsible for assisting senior staff in planning study conduct, designing case report forms (CRFs), conducting User Acceptance Testing (UAT), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators and writing and assembling submissions.
    * Maintain and audit Trial Master File to ensure inspection readiness.
    * Perform review of clinical data listings for completeness and accuracy, and escalate issues to the Clinical Operations Manager as needed*
    * Participate in cross-functional clinical team(s) in the planning and execution of clinical trials.
    * Proactively and effectively communicate the status of clinical studies to management.
    * Ensures quality delivery of study deliverables within agreed budgets and timelines.
    * Participate in the interim and final reviews of study data in preparation of regulatory submissions.
    * Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports).
    * May interact with RA/QA in responding to audits and FDA inquiries.

    EDUCATION
    * BS degree in life sciences or equivalent with minimum 5 years of related experience, or MS degree in life sciences or equivalent with minimum 3 years of experience, or PhD with 2 years of experience.

    EXPERIENCE
    * Must have 5 years of relevant experience in site monitoring, clinical project management, clinical trial practices and regulations.
    * Experience in conducting medical device and/or in-vitro diagnostics studies. Pharmaceutical background may also be considered.

    To be a best-fit your strengths must include:
    * Demonstrated excellence in teamwork, shared mindset for success, stellar interpersonal and communication skills including building rapport with team members, peers, and management.
    * Solid understanding and demonstrated experience of the clinical trial process including study design and conduct; clinical data management systems; clinical trial management systems; data analysis; and data reporting and interpretation.
    * Must have a demonstrated ability to solve problems with innovative solutions along with strong project management and organizational skills to deliver projects on time and on budget.
    * Able to manage numerous projects/conflicting priorities, and to be flexible when priorities change.
    * Working knowledge of GCP, Clinical and Regulatory Affairs.
    * Flexibility in daily activities.
    * Proficient with Microsoft Suite.

    Travel Requirements

    * Must be able to travel 30-50%


    About Advanced Clinical

    Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

    Regarding your application
    Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

    It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.

     

  • 1 Month Ago

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Senior Clinical Research Associate
  • Research & Development Institute, Inc.
  • Los Angeles, CA FULL_TIME
  • Research & Development Institute (RDI) is a tech-enabled CRO that helps In Vitro Diagnostic manufacturers who struggle to get FDA clearance for their products by sourcing the blood samples they desper...
  • 19 Days Ago

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Clinical Research Associate
  • Cognitive Research Corporation
  • Los Angeles, CA FULL_TIME
  • Position Summary: The Clinical Research Associate is responsible for tracking and maintaining study specific non-CRF databases and administrating clinical research projects. This is accomplished by co...
  • 4 Days Ago

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Clinical Research Associate
  • Translational Research in Oncology
  • Nice, CA FULL_TIME
  • If you are an experienced CRA who is passionate about oncology research and looking to join a highly skilled and knowledgeable team, TRIO is the place for you! Translational Research in Oncology (TRIO...
  • 1 Month Ago

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Clinical Research Medical Assistant
  • Clinical Research
  • Pasadena, CA FULL_TIME
  • We are seeking dynamic and motivated individuals to join our team as a Medical Assistant/ Clinical Research Assistant. This position offers a unique opportunity to contribute to cutting-edge medical r...
  • 12 Days Ago

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CNS - Clinical Research Associate (CRA) - W2
  • C-Clinical
  • San Diego, CA FULL_TIME
  • C-Clinical Our clinical research firm is expanding and we have an opportunity for a Senior CRA with CNS, oncology, or metabolic experience for our pharmaceutical company client. The site monitoring is...
  • 10 Days Ago

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Clinical Research Associate
  • Renown Health
  • Reno, NV
  • Position Purpose This position is responsible, in collaboration with the Clinical Research Coordinators, Research Nurses...
  • 3/28/2024 12:00:00 AM

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Clinical Research Associate
  • McInnis Inc.
  • Ridgefield, CT
  • The Clinical Research Associate will support clinical research activities within research sites that are actively partic...
  • 3/28/2024 12:00:00 AM

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In-House Clinical Research Associate / Senior Clinical Research Associate
  • 89bio
  • San Francisco, CA
  • THE COMPANY 89bio is a clinical-stage biopharmaceutical company focused on the development and commercialization of inno...
  • 3/28/2024 12:00:00 AM

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Clinical Research Associate
  • Alliance for Clinical Trials in Oncology
  • Boston, MA
  • The in-house CRA is responsible for managing various aspects of AFT site management and project management strategies, i...
  • 3/27/2024 12:00:00 AM

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Clinical Research Associate
  • SystImmune, Inc
  • Redmond, WA
  • Clinical Research Associate Redmond, WA SystImmune Inc. is a clinical-stage biopharmaceutical company located in Redmond...
  • 3/26/2024 12:00:00 AM

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Clinical Research Associate
  • Pride Health
  • The Scientific Team at Russell Tobin & Associates is supporting a world-class Medical Device organization that has an op...
  • 3/25/2024 12:00:00 AM

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Clinical Research Associate
  • Planet Pharma
  • Carpinteria, CA
  • 6 month contract to hire Pay dependent on experience as there are multiple openings/ levels The Clinical Research Associ...
  • 3/25/2024 12:00:00 AM

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Clinical Research Associate
  • Apex Systems
  • Memphis, TN
  • Join Our Mission to Revolutionize Genetic Neurological Disorder Research Apex Systems is on the hunt for a passionate an...
  • 3/24/2024 12:00:00 AM

California is a state in the Pacific Region of the United States. With 39.6 million residents, California is the most populous U.S. state and the third-largest by area. The state capital is Sacramento. The Greater Los Angeles Area and the San Francisco Bay Area are the nation's second and fifth most populous urban regions, with 18.7 million and 9.7 million residents respectively. Los Angeles is California's most populous city, and the country's second most populous, after New York City. California also has the nation's most populous county, Los Angeles County, and its largest county by area, S...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Associate jobs
$75,161 to $99,281

Clinical Research Associate in Vista, CA
Represents Global Clinical Affairs on multifunctional teams tasked with preparing responses to regulatory agencies.
May 02, 2023
Clinical Research Associate in Stockton, CA
Document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements.
April 20, 2023
Clinical Research Associate in Stamford, CT
Responds flexibly to changing business demands and opportunities, proactively looking for ways to contribute.
May 09, 2023
Participate in monitoring visit report review process in order to maintain oversight of clinical monitoring quality and adherence to protocol and established processes and plans.
December 03, 2022