Current jobs related to Clinical Research Associate - Irvine - Novo Nordisk

  • Research Dietitian Specialist

    5 days ago

    Irvine, California, United States Irvine Clinical Research Full time

    About the RoleWe are seeking a highly skilled Research Dietitian to join our team at Irvine Clinical Research. As a key member of our clinical trials team, you will play a crucial role in conducting lifestyle counseling visits, managing daily operations, and coordinating clinical trials.Key ResponsibilitiesConduct lifestyle counseling visits to improve...

  • Clinical Research Associate

    3 weeks ago

    Irvine, California, United States Cynet Systems Full time

    Job OverviewWe are seeking a Clinical Research Associate to support our client in their clinical research initiatives.Position Title: Clinical Research AssociateLocation: RemoteEmployment Type: ContractCompensation: $38.56/hr - $43.56/hrKey Responsibilities:Assist in the evaluation and upkeep of study and site documentation, aiding in the management of...

  • Clinical Research Associate Specialist

    1 month ago

    Irvine, United States Ledgent Technology Full time

    Assoc Clinical Research Specialist Duration - 6 Months, Contract, W-2 Location - Irvine, CA Pay - $30 - $45.05 an hour Summary:· Perform general study management support activities and assist in the processing of study/site/vendor payments in collaboration with Clinical Execution project teams.· Assist in the review, maintenance of study & site documents,...

  • Clinical Research Coordinator

    4 weeks ago

    Irvine, United States Ledgent Technology Full time

    Medical Device client is seeking a Clinical Research Coordinator/Study Manager in Irvine, CA!Assoc Spec, Clinical ResearchDuration - 1 YearLocation - Irvine, CAMax Pay - $45.05 Summary: The main function of the Associate Clinical Research Specialist, is to perform study start-up and conduct activities, ensuring clinical studies are conducted and reported in...

  • Clinical Research Coordinator

    4 weeks ago

    Irvine, United States Ledgent Technology Full time

    Medical Device client is seeking a Clinical Research Coordinator/Study Manager in Irvine, CA!Assoc Spec, Clinical ResearchDuration - 1 YearLocation - Irvine, CAMax Pay - $45.05 Summary: The main function of the Associate Clinical Research Specialist, is to perform study start-up and conduct activities, ensuring clinical studies are conducted and reported in...

  • Clinical Research Caregiver

    3 weeks ago

    Irvine, California, United States University Of California Irvine Full time

    About Us Established in 1965, University of California Irvine is a distinguished member of the Association of American Universities, consistently ranked among the top public universities in the nation. Our campus has produced five Nobel laureates and is recognized for its commitment to academic excellence, groundbreaking research, and innovation. With over...

  • Administrative Assistant

    3 weeks ago

    Irvine, United States Irvine Clinical Research Full time

    Irvine Clinical Research is now hiring an Administrative Assistant. This is a patient-facing role at the front desk that supports our team of doctors and research professionals in our mission to find new medical breakthroughs through clinical research. Job Duties Warmly greet and assist study participants in reception areas at all times, especially older...

  • Clinical Research Nurse Specialist

    21 hours ago

    Irvine, California, United States City of Hope Full time

    Transformative Care at City of HopeAt City of Hope, we're dedicated to delivering innovative and compassionate care to patients with cancer, diabetes, and other life-threatening illnesses. Our team of experts is driven by a shared mission: to make a real difference in the lives of those we serve.Key ResponsibilitiesCollaborate with physicians, Clinical...

  • Clinical Research Coordinator

    1 week ago

    Irvine, California, United States Kelly Science, Engineering, Technology & Telecom Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Study Associate to join our team at Kelly Science, Engineering, Technology & Telecom. As a Clinical Study Associate, you will provide critical support to our clinical study staff, ensuring the smooth execution of clinical trials.Key ResponsibilitiesStudy Support: Provide general...

  • Clinical Research Regulatory Specialist

    4 weeks ago

    Irvine, California, United States University Of California Irvine Full time

    Overview:Established in 1965, University of California, Irvine is recognized as a leading institution in the Association of American Universities and consistently ranks among the top public universities in the nation. With a vibrant community of over 36,000 students and a diverse array of 224 degree programs, UC Irvine is dedicated to academic excellence and...

  • Associate Clinical Research Specialist

    4 weeks ago

    Irvine, United States Cynet Systems Inc. Full time

    Education and Experience Requirements: Bachelor's Degree or equivalent in a related field. 1 year of clinical research experience required. Additional Skills: Good computer skills in MS Office Suite, including Word, Excel, Adobe, and ability to operate general computer software and office machinery. Experience with electronic data capture...

  • Clinical Research Regulatory Specialist

    3 weeks ago

    Irvine, California, United States University Of California Irvine Full time

    Overview:Established in 1965, University of California, Irvine is a distinguished member of the Association of American Universities, consistently ranked among the top public universities in the nation. The institution is recognized for its academic excellence, innovative research, and vibrant campus life. With over 36,000 students and a wide array of degree...

  • Clinical Research Coordinator

    5 days ago

    Irvine, United States Insight Global Full time

    Location: HYBRID- Tuesday and Thursdays ( every other Friday) In office Contract Duration: 1 year with possible extensions MUST HAVES:Bachelor’s degree in life sciences, nursing, or a related field.1 year of experience in clinical research or a related field.Knowledge of GCP, ICH guidelines, and regulatory requirements.Strong organizational and time...

  • Clinical Research Coordinator

    5 days ago

    Irvine, United States Insight Global Full time

    Location: HYBRID- Tuesday and Thursdays ( every other Friday) In office Contract Duration: 1 year with possible extensions MUST HAVES:Bachelor’s degree in life sciences, nursing, or a related field.1 year of experience in clinical research or a related field.Knowledge of GCP, ICH guidelines, and regulatory requirements.Strong organizational and time...

  • Clinical Research Lab RN

    2 days ago

    Irvine, United States Masimo Full time

    Job DescriptionJob SummaryThe individual in this position is responsible for assigned clinical trial projects undertaken in support of a given product line or marketing initiative within Masimo Corporation. This includes the execution, and documentation of assigned clinical studies conducted to support R&D efforts, regulatory filings (510k or PMA), or...

  • Clinical Research Lab RN

    9 hours ago

    Irvine, United States Masimo Full time

    Job Summary The individual in this position is responsible for assigned clinical trial projects undertaken in support of a given product line or marketing initiative within Masimo Corporation. This includes the execution, and documentation of assigned clinical studies conducted to support R&D efforts, regulatory filings (510k or PMA), or marketing...

  • Clinical Research Psychometrist

    1 week ago

    Irvine, California, United States University Of California Irvine Full time

    About the RoleWe are seeking a highly skilled and detail-oriented Clinical Research Psychometrist to join our interdisciplinary clinical research program at the University of California, Irvine. As a key member of our team, you will be responsible for administering standardized cognitive tests to elderly research participants and patients at our Alzheimer's...

  • Clinical Research Lab RN

    3 days ago

    Irvine, United States Masimo Full time

    Job DescriptionJob Summary The individual in this position is responsible for assigned clinical trial projects undertaken in support of a given product line or marketing initiative within Masimo Corporation. This includes the execution, and documentation of assigned clinical studies conducted to support R&D efforts, regulatory filings (510k or PMA), or...

  • Clinical Research Lab RN

    4 days ago

    Irvine, United States Masimo Full time

    Job DescriptionJob Summary The individual in this position is responsible for assigned clinical trial projects undertaken in support of a given product line or marketing initiative within Masimo Corporation. This includes the execution, and documentation of assigned clinical studies conducted to support R&D efforts, regulatory filings (510k or PMA), or...

  • Research Associate/Senior Research Associate, Microfluidics

    2 months ago

    Irvine, United States Aureka Biotechnologies, Inc. Full time

    Position: Research Associate/Senior Research Associate, MicrofluidicsLocation: Laguna Hills, CACompany: Aureka BiotechnologiesJob Type: Full-TimeReports To: Sr. DirectorAbout Us:Aureka Biotechnologies is an innovative startup focused on AI-driven antibody design to revolutionize drug development. We are a dynamic team dedicated to advancing scientific...

Clinical Research Associate

4 months ago

Irvine, United States Novo Nordisk Full time

**About the Department***

The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?

**The Position**

Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring and site management activities.

Takes ownership to deliver upon near-term North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio.

Contributes to local or increasingly complex improvement/innovation projects for the department, (subset of) NACD and/or as part of a global team and as aligned to a business case, goals and/or future aspirations.

Contributes to a continually changing environment, supporting a future-focused approach, leveraging competencies, tools and technology.

**Relationships**

Reports to a Manager (or above) within NACD.

Manages mutually beneficial relationships with external partners relevant to the planning and implementation of clinical trials and improvement/innovation projects for NACD and Novo Nordisk (e.g., clinical trial site staff, clinical research vendors).

Manages relationships with multiple internal stakeholders relevant to the planning and implementation of clinical trials and improvement/innovation projects for NACD & Novo Nordisk (e.g., across NACD, CMR, International Operations (IO), and HQ R&D).

Provides excellent customer service and builds strong working relationships with investigative sites and internal/external partners.

**Essential Functions**
- Delivers all relevant services/tasks in support of the planning and implementation of quality driven clinical trials, in line with established targets and strategies
- Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles and tools; executes activities relevant to all visit types (Site Selection, Site Initiation, Monitoring, and Closure) for assigned sites and clinical trials
- Verifies safety reporting and the proper handling, monitoring and storage of trial product according to trial specifications, NN SOPs, ICH-GCP guidelines, and relevant regulatory requirements
- Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the protocol, Monitoring Plan and other associated trial documents
- Complies with relevant training requirements. Acts as local expert in assigned protocols. Develops therapeutic area knowledge sufficient to support role and responsibilities
- Drives recruitment and retention strategies to support clinical trial sites to meet country enrollment and retention targets
- Participates in the preparation, conduct and follow-up of audit and inspection activities, collaborating with relevant internal and external stakeholders to develop and implement Corrective and Preventive Action Plans (CAPA)
- Shares information, collaborates and provides relevant input and guidance to other areas within NACD, CMR, and Global partners
- Demonstrates technical proficiency within responsible areas, staying up-to-date on new practices, systems, and technologies while building knowledge of emerging trends and advances within area

**Physical Requirements**

50-75% overnight travel required; Driver must maintain a valid driver’s license. Must be in good standing by not exceeding the Novo Nordisk points threshold assigned based on review of Motor Vehicle Records.; May be required to work company holidays and weekends. The incumbent must reside near Irvine or Palm Springs, CA.

**Qualifications**
- A minimum of 4 years of clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting is required
- A minimum of 2 years of on-site monitoring experience is required, however monitoring experience may be waived if relevant Novo Nordisk experience is demonstrated in GCP-related clinical research
- Bachelor’s degree required* (science related discipline preferred):

- Alternatively, a Registered Nurse with a minimum of 3 years of on-site monitoring experience is acceptable, in lieu of a Bachelor’s degree
- Requires understanding of medical and scientific concepts in order to effectively interpret protocol requirements, support sites and eff