What are the responsibilities and job description for the Clinical - Assoc Analyst, Clinical Operations position at TalentBurst, Inc.?

Position : Associate Analyst, Clinical Operations Req# : 9697-1

Location : Irvine, CA ( 100% onsite only)

Duration : 12 Months Contract (Part-Time job, 20 hours per week)

Part-time work schedule : PT work schedule to 4 days on-site / week (8 AM-12 PM) with the flexibility to WFH on Fridays OR candidates can choose to work 2.5 full days each week (e.g. Mon, Weds Thurs only) instead of splitting the 20 hours across 5 days if that is their preference.

More on this position :

What does your group do? The group will be supporting advanced patient monitoring rather than Critical Care

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.

Will there be any travel involved? Yes,

We need someone with a vehicle as they may need to travel between the two campuses.

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 remote work

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

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Clinical - Assoc Analyst, Clinical Operations

What are the responsibilities and job description for the Clinical - Assoc Analyst, Clinical Operations position at TalentBurst, Inc.?

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