Clinical Operations Spec 1

LanceSoft Inc

Irvine, CA

Apply

JOB DETAILS

JOB TYPE

Full-time

SKILLS

Basic Life Support (BLS), Billing, CPR Certification, Clinical Laboratory, Clinical Research, Clinical Trial, Customer Support/Service, Document Archiving, File Systems, Finance, First Aid, Healthcare, Laboratory Operations, Maintain Compliance, Manufacturing Operations, Medical Products, Medicine, Process Development, Process Improvement, Product Lifecycle, Provider Credentialing, Regulatory Compliance, Reporting Skills, Research Laboratory, Shipping/Receiving, Supply Chain, Time Management

LOCATION

Irvine, CA

POSTED

14 days ago

Clinical Operations Specialist 1 On Site Role Hours: Mon-Fri, 8am - 5pm Job Description: 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, status of open device issues/queries, etc.) 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 and process device shipment to clinical sites within our shipping timeframe to Customer Service, Trade Compliance, and other relevant stakeholders. Confirm receipt of 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 assessments (e.g., transition to new device system, system enhancements to meet supply and demand, etc) in collaboration with clinical stakeholders in order to meet key study milestones and deadlines. Ensure documentation are archived appropriately within record retention facility (e.g., Iron Mountain, clinicaltrial.gov) Track, manage, and coordinate clinical study invoice processing to ensure timely review, approval, and payment. Generate reports on outstanding invoice payments for clinical study team review Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials Maintains current and active licensure and certification(s) to administer First Aid, BLS and CPR for emergent needs in healthy volunteer clinical research studies Support clinical research laboratory operations as needed Other incidental duties as assigned Required: >1–2 years of patient-facing experience in a clinical research, healthcare, or related medical setting. Current CPR and First Aid certification from an accredited provider Preferred experience/qualifications: Associate's/Bachelor’s degree in a related field

About the Company

LanceSoft Inc

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE

2,000 to 2,499 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2000

WEBSITE

http://www.lancesoft.com/

Resume Resources

Free Resume Templates Free Resume Builder