Clinical Operations Specialist

1 month ago

Irvine, United States Planet Pharma Full time

This position is a contract-to-hire role with a leading medical device company in Irvine, CA. Candidates must have hands-on experience with medical device/imaging clinical trials, and be located in the greater Irvine, CA area and able to go onsite to be considered.


Location: Onsite 4 days a week at Irvine, CA office - no exceptions


Schedule: 8 am PST to 5 pm PST, Monday through Friday


Duration: 12 months w/ opportunities on the team to go FTE based on performance


Pay: $35-43 per hour based on experience. Medical, Dental, Vision, 401K, Life Insurance, etc available


Must haves:

  • 3-5 years of Clinical trial/research experience with medical devices. If in a cardiovascular or clinical imaging setting, a huge plus
  • Track record of supporting 3 or more ongoing trials at one time.
  • Recent work experience with EDC Medidata Rave.
  • Highly skilled in Excel & SharePoint.
  • Experienced with interpreting clinical data.


Summary:

As the Clinical Operations Analyst for our Transcatheter Heart Valve team, you will be responsible for providing project management of dynamic and high-volume core lab projects across all Transcatheter Heart Valve global clinical studies to ensure accurate and timely transfer of images from study sites to Independent Core Labs, and clinical data from Independent Core Labs to data management teams to ultimately provide unbiased study results.


Key Responsibilities:

• Analyze clinical output of moderately complex studies and provide high level summary with supporting details of study trial status (e.g., Core Lab image perspective) to stakeholders and clinical management

• Identify technical and data issues and collaborate with appropriate team members to bring to resolution; assist in the determination of root cause and recommend and implement corrective actions

• Identify, develop, recommend, and implement moderately complex process development and process improvement solutions to optimize global trial workflow timelines, (e.g., open information requests, aging issues, status of image analysis from Core Labs to study database, etc.)

• Develop basic timeline assessment and/or work with senior level team members on complex timeline assessment (e.g., clinical site through Image workflow vendor to Independent Core Lab) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines

• Provide guidance and represent department to communicate risk and impact to study core team's key milestones and deliverables

• Assist in the development of training material content in collaboration with clinical stakeholders for clinical sites and clinical field staff


Additional Skills:

• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery

• Experience with an ERP software, JDE and CTMS (Clinical Trial Management System) preferred

• Good written and verbal communication skills and interpersonal relationship skills

• Ability to work in a fast paced environment

• Substantial knowledge and understanding of policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation

• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint

• Good problem-solving skills

• Ability to manage confidential information with discretion

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Must be able to work in a team environment under minimal supervision

• No instructions needed on routine work, and general instructions given only on new lines of work or special assignments

• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control


Required Education and Experience:

•Bachelor's Degree in STEM or healthcare

•3-5 years of hands-on clinical research experience in Medical Devices

  • Clinical Operations Specialist

    4 weeks ago

    Irvine, California, United States Planet Pharma Full time

    Clinical Operations Specialist - Medical DevicesThis position is a contract-to-hire role with Planet Pharma, a leading medical device company. The ideal candidate will have hands-on experience with medical device/imaging clinical trials and be located in the greater Irvine, CA area.Key ResponsibilitiesAnalyze clinical output of moderately complex studies and...

  • Clinical Research Specialist

    3 weeks ago

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

    Join Kelly FSP as a Clinical Research Specialist with our Medical Device client in Irvine, CAThis is a hybrid position Tuesday/Thursday and every other Friday on site. RESPONSIBILITIESServes as a Clinical Research Specialist within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device...

  • Clinical Research Specialist

    2 weeks ago

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

    Join Kelly FSP as a Clinical Research Specialist with our Medical Device client in Irvine, CAThis is a hybrid position Tuesday/Thursday and every other Friday on site. RESPONSIBILITIESServes as a Clinical Research Specialist within the Clinical R&D Operations CoE operations group to execute company sponsored clinical trials for the Medical Device...

  • Clinical Research Dietitian

    1 month ago

    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...

  • Clinical Research Specialist

    2 months ago

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

    Join Kelly FSP as Clinical Research Specialist at our client site in Irvine, CA.This is a Hybrid Position. Monday, Wednesday and every other Friday on site.JOB SUMMARYThis Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with...

  • Financial Operations Manager

    1 month ago

    Irvine, California, United States Irvine Clinical Research Full time

    Controller Job DescriptionIrvine Clinical Research is a leading clinical research company on the West Coast, with a strong presence in neurology, psychiatry, and obesity medicine. Our company is at the forefront of Alzheimer's Disease prevention and treatment drug trials, and our doctors have made significant contributions to the most recently FDA-approved...

  • Clinical Specialist Orange County

    5 months ago

    Irvine, United States Accordance Search Group Full time

    The Field Clinical Specialist works using independent judgement, partners with local Account Managers to increase clinical support, education resulting in clinical acumen.  This role will entail educating physicians on device handling, implementation and troubleshooting techniques.  Also, develop and lead training sessions and in-services.  Must be...

  • Senior Clinical Research Specialist

    2 months ago

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

    Join Kelly FSP as a Senior Clinical Research Specialist with this hybrid role at our Client Site in Irvine, CA!Hybrid: On site Monday, Wednesday and every other Friday. Job DescriptionThis Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive...

  • Senior Clinical Research Specialist

    2 months ago

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

    Join Kelly FSP as a Senior Clinical Research Specialist with this hybrid role at our Client Site in Irvine, CA!Hybrid: On site Monday, Wednesday and every other Friday. Job DescriptionThis Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive...

  • Sr Clinical Research Specialist

    3 weeks ago

    Irvine, United States Kelly Full time

    Kelly Science and Clinical FSP is currently seeking a Sr Clinical Research Specialist for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering...

  • Sr Clinical Research Specialist

    2 weeks ago

    Irvine, United States Kelly Full time

    Kelly Science and Clinical FSP is currently seeking a Sr Clinical Research Specialist for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering...

  • Clinical Operations Manager

    1 month ago

    Irvine, California, United States Lollipop Pediatric Dentistry & Orthodontics Full time

    Job Summary:We are seeking a highly skilled and experienced Clinical Manager to oversee the clinical operations of our pediatric and orthodontic dental practice. The ideal candidate will have a strong background in dental management, excellent leadership skills, and a passion for delivering exceptional patient care.Key Responsibilities: Oversee daily...

  • Clinical Safety Specialist

    2 weeks ago

    Irvine, California, United States MSCCN Full time

    Foster collaboration and scientific curiosity to drive clinical practices and impact patient lives. As a Senior Specialist, Clinical Safety, you will oversee adverse events, develop training programs, and educate enrolling sites to ensure protocol requirements are followed.Key Responsibilities:Provide oversight on safety processes from site to CEC to ensure...

  • Senior Quality Assurance Clinical Laboratory Specialist

    2 weeks ago

    Irvine, California, United States TCWGlobal Full time

    Job DescriptionWe are seeking a Senior Quality Assurance Clinical Laboratory Specialist to support the testing and documentation needs of the Quality Control Department during the manufacture and release of company control products.Key Responsibilities:Operate, maintain, and troubleshoot QC Laboratory instrumentationFollow performing good laboratory...

  • Gaming Operations Specialist

    1 month ago

    Irvine, United States Volt Full time

    Job DescriptionJob DescriptionAchieve more with VoltVolt is hiring for a remote Gaming Operations Specialist (Global Network) in Irvine, CA.Reduce your CommuteThe role is focused on rapid detection, triage, and mitigation of player-impacting issues and continuous improvement of service operations processes by adjusting monitoring, tuning signal to noise &...

  • Operations Specialist

    1 week ago

    Irvine, United States Volt Workforce Solution Full time

    Job DescriptionJob DescriptionLet your career thrive with Volt   Volt is immediately hiring for a Operations Specialist with Assembly Experience.   As an Operations Specialist you will:Understanding of Production and Material ControlBasic assemblyUnderstanding of MRP systemsMedical device assembly of all product lines, including medical devices, bottled...

  • Gaming Operations Specialist

    2 weeks ago

    Irvine, United States Volt Full time

    br />Achieve more with VoltVolt is hiring for a remote Gaming Operations Specialist (Global Network) in Irvine, CA.Reduce your CommuteThe role is focused on rapid detection, triage, and mitigation of player-impacting issues and continuous improvement of service operations processes by adjusting monitoring, tuning signal to noise & correlation patterns, and...

  • Operations Support Specialist

    6 hours ago

    Irvine, United States Essex Property Trust Full time

    City Fountain ValleyState CaliforniaJob Location OCC 504 The HavensPosition Type Regular POSITION SUMMARY The Operations Support Specialist is an integral member of the Operations Staff Services Team, a team that functions as a point of support for operations. The Operations Support Specialist will be accountable for a variety of tasks and projects which...

  • Senior Clinical Operations Director

    1 week ago

    Irvine, California, United States Lollipop Pediatric Dentistry & Orthodontics Full time

    We are seeking a skilled and experienced Clinical Manager to oversee the clinical operations at Lollipop Pediatric Dentistry & Orthodontics. As a key member of our team, you will be responsible for ensuring exceptional patient care, compliance with clinical protocols, and the efficient functioning of the dental team.Key Responsibilities:Clinical...

  • Gaming Operations Specialist

    1 week ago

    Irvine, United States Volt Full time

    Achieve more with VoltVolt is hiring for a remote Gaming Operations Specialist (Global Network) in Irvine, CA.Reduce your CommuteThe role is focused on rapid detection, triage, and mitigation of player-impacting issues and continuous improvement of service operations processes by adjusting monitoring, tuning signal to noise & correlation patterns, and...