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Clinical Research Associate Specialist

2 months ago

Irvine, United States Ledgent Technology Full time

Assoc Clinical Research Specialist

Duration - 6 Months, Contract, W-2

Location - Irvine, CA

Pay - $30 - $45.05 an hour

Summary:

· Perform general study management support activities and assist in the processing of study/site/vendor payments in collaboration with Clinical Execution project teams.

· Assist in the review, maintenance of study & site documents, supporting the management of document files and associated quality review activities

· Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases

· Conduct in-house reviews of associated documentation and may support internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, internal SOPs, and US and OUS regulations (as needed)

· Assess current processes, identify opportunities and propose solutions to improve process efficiencies, tracking and reporting

· Assist and support the timely review, tracking, and processing of study, site & vendor payments (ie. processing of invoices)

· Assist in the reconciliation and tracking of payment queue status and totals by cost center

· Partner with cross-functional team (e.g., finance, clinical execution, accounts payable, monitoring etc.) for general site payment issue resolution & support

Additional Skills:

· Bachelor's Degree & 1-3 years relavant experience required

· Clinical research background required with clinical study process knowledge

· Experience in TMF document management systems (Veeva), CTMS (Medidata Rave), past exposure with invoice/payments processing and tracking in Coupa

· Verbal and written communication skills, attention to detail, and critical thinking


All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. To the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.