Clinical Research Associate jobs in Thousand Oaks, CA

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Sr. Associate Manager, Clinical Research (CONTRACT TO HIRE)
  • MannKind Corporation
  • Westlake, CA FULL_TIME
  • At MannKind our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.

    MannKind Corporation is currently seeking a Sr. Associate Manager, Clinical Research. This role is an integral member of the clinical operations team, supporting strategic planning for Phase 1 through 4 clinical trials to ensure the safety and effectiveness of MannKind products. Specific activities include contributing to clinical trial plans, various aspects of clinical trial operations in collaboration with Clinical Research Organizations (CRO) and other external parties, study recruitment efforts and data analysis.

    The Sr. Associate Manager, Clinical Research provides technical and administrative support for multiple studies and must ensure that all activities are in compliance with current local and international regulations, laws, guidance (for example, FDA, ICH, CPMP etc.), and Good Clinical Practices (GCPs). This position is contract to direct hire.

    Essential Duties and Job Functions:
    • Assists with the development and management of study related documents including clinical protocols, case report forms, study manuals, operational plans, recruitment content, and other study materials.
    • Ensures readiness of study supplies, study tools, devices, and investigational products (IP) for use in clinical trials.
    • Tracks and reports progress of studies including site certifications, subject enrollment, data collection, documentation of adverse events, and real-time study data
    • Creates and maintains registry postings, such as clintrials.gov
    • Initiates contracts and provides operational oversight of vendors and other external third parties such as patient advocacy groups and CROs
    • Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for study related meetings
    • Maintains relationships and addresses questions regarding procedural issues from clinical sites and helps identify areas of improvement
    • Assists in the identification and assessment of clinical sites for study participation
    • Supports site certification procedures including Investigator Meeting and Site Initiation Meeting planning, and preparation and presentation of training materials
    • Manages and maintains study Trial Master Files (TMF), including scheduled reconciliation, and escalates any issues to study leads
    • Assists in the preparation and review of regulatory documents (for example IND annual reports, safety reports, Investigator Brochures, etc.)
    • Supports data analysis, research, and scientific exchange through statistical analysis, literature research, and scientific publication
    • Contributes to process improvement initiatives, SOP development, and document revisions
    Knowledge, Experience and Skills:
    • Requires a four-year degree (in biological, physical, engineering sciences or related discipline) and related experience in clinical operations such as in a pharmaceutical, medical device, research, or academic
      • 3 years of relevant clinical operations experience directly supporting clinical study conduct
      • 1 years of relevant clinical operations experience directly supporting clinical study conduct with a MS degree
      • No additional experience with a PharmD degree
    • Requires excellent verbal and written communication skills and interpersonal skills to build/maintain strong relationships with clinical sites, vendors, patient advocacy groups and internal team
    • Demonstrated ability to be a fast learner, with strong attention to detail
    • Demonstrated ability to solve problems and manage multiple tasks
    • Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed
    • Demonstrated ability to analyze and interpret data and communicate conclusions clearly and concisely
    • Demonstrated ability to work effectively within multidisciplinary teams
    • Proficient in Microsoft Office products (Word, Excel, PowerPoint, etc.), including SharePoint and other collaboration tools.
    • Knowledge of GCP and regulatory compliance guidelines for clinical trials (e.g. applicable ISO Standards, FDA) preferred
    • Knowledge and experience with diabetes and/or orphan lung therapeutic area preferred

  • 3 Days Ago

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Clinical Research Assistant
  • Care Access
  • Thousand Oaks, CA FULL_TIME
  • What We Do Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physici...
  • 9 Days Ago

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Clinical Research Operations Internship
  • Mannkind Corporation
  • Westlake, CA FULL_TIME
  • Position: Clinical Research Operations Internship Location: Westlake Village, CA Job Id: 11056 # of Openings: 1 Internship Overview: Clinical Operations Intern We are seeking a highly motivated and de...
  • 2 Months Ago

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Clinical Research Coordinator, Westlake Village
  • University of California - Los Angeles Health
  • Westlake, CA FULL_TIME
  • DescriptionThe Clinical Research Coordinator contributes to the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. In this role,...
  • 9 Days Ago

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Clinical Research Coordinator, Westlake Village
  • UCLA Health Careers
  • Westlake, CA FULL_TIME
  • DescriptionThe Clinical Research Coordinator contributes to the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. In this role,...
  • 11 Days Ago

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Research Associate II
  • Pennymac
  • Moorpark, CA FULL_TIME
  • PENNYMAC Pennymac (NYSE: PFSI) is a specialty financial services firm with a comprehensive mortgage platform and integrated business focused on the production and servicing of U.S. mortgage loans and ...
  • 1 Month Ago

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0 Clinical Research Associate jobs found in Thousand Oaks, CA area

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Senior Clinical Research Coordinator
  • UCLA Health
  • Encino, CA
  • General Information Press space or enter keys to toggle section visibility Work Location: Encino, USA Onsite or Remote F...
  • 4/23/2024 12:00:00 AM

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Clinical Research Associate I - Lung Institute Biobank (On-Site)
  • Cedars-Sinai
  • Los Angeles, CA
  • **Job Description** When the work you do every single day has a crucial impact on the lives of others, every effort, eve...
  • 4/22/2024 12:00:00 AM

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Clinical Research Coordinator
  • RadNet
  • Westlake Village, CA
  • Overview: Artificial Intelligence; Advanced Technology; The very best in patient care. With decades of expertise, we are...
  • 4/22/2024 12:00:00 AM

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Clin Research Assoc I/CPT PRDM/Cheng Lab
  • Cedars-Sinai
  • Los Angeles, CA
  • **Job Description** JOB SUMMARY: The Clinical Research Associate I works directly with a Clinical Research Coordinator, ...
  • 4/22/2024 12:00:00 AM

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Clinical Research Coordinator I / Endocrinology
  • Children's Hospital Los Angeles
  • Los Angeles, CA
  • NATIONAL LEADERS IN PEDIATRIC CARE Ranked among the top 10 pediatric hospitals in the nation, Children's Hospital Los An...
  • 4/21/2024 12:00:00 AM

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Clinical Research Associate I - Department of Neurology (Hybrid)
  • Cedars-Sinai
  • Los Angeles, CA
  • **Job Description** When the work you do every single day has a crucial impact on the lives of others, every effort, eve...
  • 4/20/2024 12:00:00 AM

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Clinical Research Associate I - Smidt Heart Institute (Makkar)
  • Cedars-Sinai
  • Los Angeles, CA
  • **Job Description** **Grow your career at Cedars-Sinai!** The Smidt Heart Institute reflects Cedars-Sinai's steadfast de...
  • 4/19/2024 12:00:00 AM

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Clinical Research Coordinator, Santa Monica
  • UCLA Health
  • Santa Monica, CA
  • General Information Press space or enter keys to toggle section visibility Work Location: Santa Monica, USA Onsite or Re...
  • 4/19/2024 12:00:00 AM

Thousand Oaks is the second-largest city in Ventura County, California, United States. It is in the northwestern part of Greater Los Angeles, approximately 40 miles (64 km) from Downtown Los Angeles and is less than 15 miles (24 km) from the Los Angeles neighborhood of Woodland Hills. It is named after the many oak trees present in the area, and the city seal is adorned with an oak. The city forms the central populated core of the Conejo Valley. Thousand Oaks was incorporated in 1964, but has since expanded to the west and east. Two-thirds of neighboring Westlake Village and most of Newbury Pa...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Associate jobs
$73,919 to $97,634
Thousand Oaks, California area prices
were up 2.5% from a year ago

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