Clinical Research Associate jobs in Ventura, 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

  • 4 Days Ago

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Clinical Research Operations Internship
  • MannKind Corporation
  • Westlake, CA FULL_TIME
  • Internship Overview: Clinical Operations Intern We are seeking a highly motivated and detail-oriented Clinical Operations Intern to join our team. This internship will provide invaluable hands-on expe...
  • Just Posted

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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...
  • 10 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,...
  • 10 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,...
  • 12 Days Ago

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0 Clinical Research Associate jobs found in Ventura, CA area

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Clinical Research Associate to CTM
  • Planet Pharma
  • Carpinteria, CA
  • Primary Responsibilities (all levels): Performs all study monitoring visits and completes supporting visit reports, incl...
  • 4/24/2024 12:00:00 AM

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Primary Care Clinic Senior Registered Nurse
  • County of Ventura (CA)
  • Ventura, CA
  • Description What We Offer The County of Ventura offers an attractive compensation and benefits package, subject to eligi...
  • 4/24/2024 12:00:00 AM

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Clinical Educator LVN
  • CommonSpirit Health
  • Ventura, CA
  • Overview: Dignity Health Medical Foundation established in 1993 is a California nonprofit public benefit corporation wit...
  • 4/24/2024 12:00:00 AM

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Clinical Research Coordinator
  • RadNet Ventura (Rolling Oaks Radiology)
  • 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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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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Clinical Research Associate to CTM
  • Planet Pharma
  • Carpinteria, CA
  • Primary Responsibilities (all levels): Performs all study monitoring visits and completes supporting visit reports, incl...
  • 4/21/2024 12:00:00 AM

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Medical Assistant
  • California Retina Consultants
  • Santa Barbara, CA
  • OphthalmicTechnician (Medical Assistant) As an Ophthalmic Technician you will preform a number of pre-exam diagnostic te...
  • 4/21/2024 12:00:00 AM

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Ophthalmic Technician
  • California Retina Consultants
  • Santa Barbara, CA
  • OphthalmicTechnician (Medical Assistant) As an Ophthalmic Technician you will preform a number of pre-exam diagnostic te...
  • 4/21/2024 12:00:00 AM

Ventura is located northwest of Los Angeles on the California coast. The western portion of the city stretches north along the Ventura River and is characterized by a narrow valley with steeply sloped areas along both sides. The steep slopes of the Ventura foothills abut the northern portion of the community. Much of the eastern portion is on a relatively flat alluvial coastal plain lying along the western edge of the Oxnard Plain. The Santa Clara River forms the city's southerly boundary with the city limits reaching up to the beginning of the Santa Clara River Valley at the historic communit...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Clinical Research Associate jobs
$73,236 to $96,731
Ventura, California area prices
were up 2.5% from a year ago

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Create, test and maintain SAS programs for clinical studies according to departmental standard procedures.
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Clinical Research Associate in Cleveland, OH
Operates effectively as a team member or leader with an understanding of team dynamics.
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Clinical Research Associate in Laguna Hills, CA
Meet with staff on an annual basis to develop and implement career goals in order to encourage and promote professional growth and development.
May 06, 2023