• Job Description

  Req#: 24-15087

  Position: Associate Analyst, Clinical Operations, Req#: 8173-1

  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.

  Will there be any travel involved? Travel is not required for this position but may occur with agreement from both parties.

  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 skills: Clinical 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

  
  TB_PH

• About the company

  Founded in 2002, TalentBurst is the national leader staffing supplier to large MSP contingent workforce programs. Through our 4 delivery centers in Boston, San Francisco, Miami and Gurgaon, India we support 90 Fortune 500 customers every week filling I...

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