Clinical Research Coordinator

2 weeks ago


Irvine CA United States TalentBurst, an Inc 5000 company Full time

Position: Associate Analyst, Clinical Operations Req#: 8877-1

Location: Irvine, CA (100% onsite only)

Duration: 9+ Months Contract (Part-Time job, 20 hours per week)

Schedule:

Monday-Friday 8 am-12 pm

100% ONSITE

NO REMOTE OR HYBRID

More on this position:

What does your group do? Clinical Affairs - Support clinical research initiatives within the Critical Care business unit.

Does your team use any specific technology/software you want us to look out for? JDE, SharePoint, MS Office Suite, EDC, TMF, CTMS

What will a typical workday look like? Clinical study device management activities such as ordering devices, coordinating international and domestic shipments, facilitating the return of study devices and equipment, managing clinical study and research laboratory device inventory, completes associated clinical study documentation as needed. This is a collaborative role, which requires solid communication skills and very good attention to detail.

What will the work schedule be?Can any overtime be expected? Part-Time. No overtime is expected.

Monday-Friday 8am-12pm

100% ONSITE (5 days a week)

NO REMOTE OR HYBRID

Will there be any travel involved? Yes,

We need someone with a vehicle as they may need to travel between the two campuses. The group will be supporting advanced patient monitoring rather than Critical Care.

Travel frequency: Could be once a month, could be twice a week (per business need)

Will you consider remote work? If yes, will they need to be in a specific time zone? No

What are your top 3 required technical skills? Must haves? Preferred technical skillsClinical research coordination, clinical study management, study document (e.g. ICF) and CRF (case report form) review

What are nice to have skills? EDC, CTMS, Veeva (TMF), GCP training, experience with medical device studies

Is there anything that would automatically disqualify a candidate? No prior clinical research experience

Job Description:

Education and Experience:

  • Bachelor's Degree
  • 0-2 years of experience

Additional Skills:

  • Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
  • Good written and verbal communication skills and interpersonal relationship skills
  • Ability to work in a fast-paced environment
  • Strict attention to detail

Key Responsibilities:

  • Develop and execute device processes associated with clinical trials. Ensure compliance with regulations and manage the lifecycle of devices, while closely partnering with other internal key stakeholders ( e.g., clinical study teams, Manufacturing Operations, Finance, Supply Chain, Quality, and Compliance groups) to develop and lead the execution of the device process and ensuring continuous process improvement of efficiency and accuracy of processes and procedures.
  • Verify inventory in JDE and process device shipment to clinical sites within our shipping timeframe to Customer Service, Trade Compliance, and Warehouse. Confirm receipt of the product with the clinical site and obtain copies of signed and dated packing slips. Monitor device inventory by coordinating with Supply Chain and Clinical Specialists
  • Develop timeline assessment (e.g., transition to new device system, system enhancements to meet supply and demand, etc) in collaboration with clinical stakeholders to meet key study milestones and deadlines.
  • Ensure documentation is archived appropriately within the record retention facility (e.g., Iron Mountain, clinicaltrial.gov)
  • Review and ensure accuracy and completeness of clinical study files, enter them into computerized tracking system, and file/scan for archive, for multiple clinical research trials
  • Identify, develop, recommend, and implement, moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., device return aging issues, the status of open device issues/queries, etc.)
  • Support clinical research laboratory operations as needed
  • Other incidental duties as assigned


  • Irvine, California, United States Irvine Clinical Research Full time

    Job SummaryIrvine Clinical Research is a leading independent clinical trial group on the West Coast, and we're expanding our research in GLP-1 analogs. As a Research Dietitian/Coordinator, you'll play a crucial role in these clinical trials, counseling study participants on lifestyle measures while coordinating clinical trials.Key ResponsibilitiesConduct...

  • Research Dietitian

    4 weeks ago


    Irvine, United States Irvine Clinical Research Full time

    Irvine Clinical Research is the largest independent clinical trial group on the West Coast. We're expanding our research in GLP-1 analogs, testing the efficacy and safety of new investigational drugs in overweight and obese participants. Can these agents help participants manage their weight, reduce cardiovascular events, or even help with conditions such as...


  • Irvine, California, United States Irvine Clinical Research Full time

    Unlock the Future of Clinical ResearchIrvine Clinical Research is a leading independent clinical trial group on the West Coast, dedicated to advancing life-changing treatments. We're expanding our research in GLP-1 analogs, investigating the efficacy and safety of new investigational drugs in overweight and obese participants.As a Research...

  • Registered Nurse

    2 days ago


    Baltic, SD, United States Avera Research Institute Full time

    Join the team at Avera! Award Winning Health Care: Avera has been named among the nation's 15 Top Health Systems, Forbes list of America's Best-in-State Employers and Level 10 Most Wired Health Care Organization by CHIME. Culture: Be part of a multidisciplinary team built on teamwork, with compassion and the goal of Moving Health Forward for you and our...


  • US-, United States PennState Health Full time

    PennState Health is seeking a highly skilled and dedicated Clinical Research Coordinator to join our team in Campbelltown, Pennsylvania. As a key member of our clinical research team, you will be responsible for the implementation of clinical research protocols under the direction of Physician Investigators and/or Clinical Research Specialists and...

  • Registered Nurse

    2 days ago


    Larchwood, IA, United States Avera Research Institute Full time

    Join the team at Avera! Award Winning Health Care: Avera has been named among the nation's 15 Top Health Systems, Forbes list of America's Best-in-State Employers and Level 10 Most Wired Health Care Organization by CHIME. Culture: Be part of a multidisciplinary team built on teamwork, with compassion and the goal of Moving Health Forward for you and our...

  • Registered Nurse

    2 days ago


    Hartford, SD, United States Avera Research Institute Full time

    Join the team at Avera! Award Winning Health Care: Avera has been named among the nation's 15 Top Health Systems, Forbes list of America's Best-in-State Employers and Level 10 Most Wired Health Care Organization by CHIME. Culture: Be part of a multidisciplinary team built on teamwork, with compassion and the goal of Moving Health Forward for you and our...

  • Registered Nurse

    2 days ago


    Crooks, SD, United States Avera Research Institute Full time

    Join the team at Avera! Award Winning Health Care: Avera has been named among the nation's 15 Top Health Systems, Forbes list of America's Best-in-State Employers and Level 10 Most Wired Health Care Organization by CHIME. Culture: Be part of a multidisciplinary team built on teamwork, with compassion and the goal of Moving Health Forward for you and our...

  • Registered Nurse

    2 days ago


    Lennox, SD, United States Avera Research Institute Full time

    Join the team at Avera! Award Winning Health Care: Avera has been named among the nation's 15 Top Health Systems, Forbes list of America's Best-in-State Employers and Level 10 Most Wired Health Care Organization by CHIME. Culture: Be part of a multidisciplinary team built on teamwork, with compassion and the goal of Moving Health Forward for you and our...


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

    Job Summary We are seeking a highly skilled Clinical Research Coordinator Assistant to join our team at the University of California, Irvine. As a key member of our clinical research team, you will be responsible for coordinating clinical trials, managing data, and ensuring the timely and accurate collection of data submission to study sponsors. Key...


  • Orlando, FL, United States Charter Research Full time

    Clinical Research DirectorOrlandoClinical Research DirectorCharter Research is dedicated to the discovery of future medicines to improve the lives of your family, friends, and neighbors. At our research centers in Orlando and The Villages, Florida, we conduct clinical trials to test innovative new treatments so that people everywhere can live healthier...

  • Registered Nurse

    2 days ago


    Beaver Creek, MN, United States Avera Research Institute Full time

    Join the team at Avera! Award Winning Health Care: Avera has been named among the nation's 15 Top Health Systems, Forbes list of America's Best-in-State Employers and Level 10 Most Wired Health Care Organization by CHIME. Culture: Be part of a multidisciplinary team built on teamwork, with compassion and the goal of Moving Health Forward for you and our...

  • Registered Nurse

    2 days ago


    Dell Rapids, SD, United States Avera Research Institute Full time

    Join the team at Avera! Award Winning Health Care: Avera has been named among the nation's 15 Top Health Systems, Forbes list of America's Best-in-State Employers and Level 10 Most Wired Health Care Organization by CHIME. Culture: Be part of a multidisciplinary team built on teamwork, with compassion and the goal of Moving Health Forward for you and our...

  • Registered Nurse

    3 days ago


    Worthing, SD, United States Avera Research Institute Full time

    Join the team at Avera! Award Winning Health Care:  Avera has been named among the nation’s 15 Top Health Systems, Forbes list of America’s Best-in-State Employers and Level 10 Most Wired Health Care Organization by CHIME. Culture:  Be part of a multidisciplinary team built on teamwork, with compassion and the goal of Moving Health Forward...

  • Registered Nurse

    3 days ago


    Canton, SD, United States Avera Research Institute Full time

    Join the team at Avera! Award Winning Health Care:  Avera has been named among the nation’s 15 Top Health Systems, Forbes list of America’s Best-in-State Employers and Level 10 Most Wired Health Care Organization by CHIME. Culture:  Be part of a multidisciplinary team built on teamwork, with compassion and the goal of Moving Health Forward...

  • Registered Nurse

    3 days ago


    Brandon, SD, United States Avera Research Institute Full time

    Join the team at Avera! Award Winning Health Care:  Avera has been named among the nation’s 15 Top Health Systems, Forbes list of America’s Best-in-State Employers and Level 10 Most Wired Health Care Organization by CHIME. Culture:  Be part of a multidisciplinary team built on teamwork, with compassion and the goal of Moving Health Forward...

  • Registered Nurse

    3 days ago


    Hartford, SD, United States Avera Research Institute Full time

    Join the team at Avera! Award Winning Health Care:  Avera has been named among the nation’s 15 Top Health Systems, Forbes list of America’s Best-in-State Employers and Level 10 Most Wired Health Care Organization by CHIME. Culture:  Be part of a multidisciplinary team built on teamwork, with compassion and the goal of Moving Health Forward...


  • , OH, United States University Hospitals Health System Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Research Specialist to join our team at the Center for Clinical Research. The successful candidate will assist with the coordination and implementation of assigned clinical research trials, ensuring compliance with regulatory guidelines and sponsor requirements.Key...


  • united states Talent4Health Full time

    Talent4Health is seeking a Clinical Research Coordinator for a travel assignment in a clinical research setting.Job DetailsSpecialty: Clinical Research CoordinatorDiscipline: Allied Health ProfessionalEmployment Type: TravelTalent4Health is a leader in providing comprehensive talent solutions for the healthcare industry. We offer a range of career...


  • Glendale, CA, United States Parexel International Corporation Full time

    Join Parexel's team of changemakers as we help advance healthcare throughout the globe, all while keeping the patient at the heart of everything we do.Job Title: Data Entry CoordinatorWork Location: onsite in Glendale, CAJob Introduction At Parexel, we are a leading Clinical Research Organization company specializing in delivering life-changing medicines to...