Current jobs related to Clinical Research Associate II - Alameda - Collabera

  • Clinical Research Associate II

    4 months ago

    Alameda, United States Collabera Full time

    Job DescriptionJob Description·         Must have a minimum of 2 years experience with "clinical research monitoring".·         Responsible for writing basic study protocols, monitoring or overseeing monitoring of investigational sites to ensure protocol adherence, assuring timely enrollment of patients and retrieval of CRFs from study...

  • Clinical Research Associate III

    4 days ago

    Alameda, California, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.Job DescriptionWe are seeking a...

  • Lead Clinical Research Associate

    2 months ago

    Alameda, United States Abbott Full time

    The Opportunity This position works out of our Alameda, CA location in the Abbott Diabetes Care Division, where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new...

  • Clinical Research Associate

    2 weeks ago

    Alameda, California, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people...

  • Lead Clinical Research Associate

    2 months ago

    Alameda, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Job...

  • Lead Clinical Research Associate

    2 months ago

    Alameda, United States Abbott Laboratories Full time

    Job DescriptionWorking at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:Career development with an international company where you can grow the career you dream of.Free medical coverage for employees* via the Health Investment Plan (HIP)...

  • Associate Clinical Research III

    4 weeks ago

    Alameda, United States Abbott Laboratories Full time

    Job DescriptionAbout AbbottAbbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live...

  • Senior Clinical Research Manager

    4 weeks ago

    Alameda, California, United States Abbott Full time

    About AbbottAbbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our extensive range of innovative technologies encompasses diagnostics, medical devices, nutritional products, and branded generic medicines, serving over 160 countries with a workforce of 114,000...

  • Research And Development Associate

    2 weeks ago

    Alameda, United States Planet Pharma Full time

    Research Associate – Research and Development – In vitroOur Client is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers, out client is overcoming the limitations of current genome editing technologies by...

  • Research And Development Associate

    2 weeks ago

    Alameda, United States Planet Pharma Full time

    Research Associate – Research and Development – In vitroOur Client is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers, out client is overcoming the limitations of current genome editing technologies by...

  • Senior Research Associate

    2 weeks ago

    Alameda, United States Planet Pharma Full time

    Research Associate – Research and Development – In vitroOur Client is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers, out client is overcoming the limitations of current genome editing technologies by...

  • Senior Research Associate

    2 weeks ago

    Alameda, United States Planet Pharma Full time

    Research Associate – Research and Development – In vitroOur Client is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Founded by CRISPR inventors and leading molecular engineers, out client is overcoming the limitations of current genome editing technologies by...

  • Accounting Specialist II

    3 weeks ago

    Alameda, California, United States Alameda Alliance Full time

    Job SummaryThe Alameda Alliance is seeking a highly skilled Financial Analyst II to join our team. As a key member of our finance department, you will be responsible for performing general and specialized accounting duties, including preparing financial reports and analyses, providing financial analysis and support, and managing balance sheet accounts.Key...

  • Sr. Research Associate

    3 weeks ago

    Alameda, United States Planet Pharma Full time

    614191Our client, a leading Medical Biotechnology company in Alameda, CA , is looking for a Sr. Research Associate to to develop formulations for its CRISPR by Design™ platform. The ideal candidate should have a good understanding of lipid nanoparticle formulations by various mixing and downstream processing techniques.Skills:BS with 5+ years of...

  • Sr. Research Associate

    1 month ago

    Alameda, United States Planet Pharma Full time

    614191Our client, a leading Medical Biotechnology company in Alameda, CA , is looking for a Sr. Research Associate to to develop formulations for its CRISPR by Design™ platform. The ideal candidate should have a good understanding of lipid nanoparticle formulations by various mixing and downstream processing techniques.Skills:BS with 5+ years of...

  • Senior Research Associate

    2 weeks ago

    Alameda, California, United States Planet Pharma Full time

    Job SummaryPlanet Pharma is seeking a highly skilled and motivated Senior Research Associate - Biopharma Innovation to join our team in the development of novel CRISPR-based therapeutics. As a key member of our research team, you will be responsible for planning, performing, and analyzing experiments to support the discovery and development of new...

  • Senior Clinical Data Manager II

    3 days ago

    Alameda, California, United States EXELIXIS Full time

    Job SummaryWe are seeking a highly skilled Senior Clinical Data Manager II to join our team at Exelixis. As a key member of our Clinical Data Management department, you will be responsible for overseeing the execution of data management activities at the program level, from study start-up through to regulatory submission.Key ResponsibilitiesProvide oversight...

  • Judicial Research Attorney

    4 weeks ago

    Alameda, California, United States The San Mateo County Bar Association Full time

    Legal Research Attorney - San Mateo County Bar AssociationThe San Mateo County Bar Association is seeking qualified candidates for the role of Legal Research Attorney. In this position, the Legal Research Attorney will undertake a range of intricate legal tasks, including conducting thorough research and providing expert consultation for judicial officers,...

  • Legal Research Specialist

    4 weeks ago

    Alameda, California, United States The San Mateo County Bar Association Full time

    Legal Research Attorney - San Mateo County Bar AssociationThe San Mateo County Bar Association is seeking candidates for the role of Legal Research Attorney. In this position, the Legal Research Attorney is responsible for conducting intricate legal analysis and providing consultation services to judicial officers, court personnel, and involved parties. This...

  • Legal Research Specialist

    4 weeks ago

    Alameda, California, United States The San Mateo County Bar Association Full time

    Legal Research Attorney - San Mateo County Bar AssociationThe San Mateo County Bar Association is seeking qualified candidates for the role of Legal Research Attorney. In this position, the Legal Research Attorney is responsible for conducting extensive legal analysis and providing consultation to judicial personnel, court staff, and litigants. The role...

Clinical Research Associate II

3 months ago

Alameda, United States Collabera Full time
Job DescriptionJob Description
  • The CRAII/Sr. CRA 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.

    Essential Duties and 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 and Experience:
  • 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.
  • 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.

    Skills:
  • 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 MS Suite.

 

Travel Requirements:

  • Must be able to travel 30-50%

 

Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.Company DescriptionCollabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.