In-House Clinical Research Associate

October 3

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Alira Health

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Nuclear medicine • Rare disease • Lupus • Myasthenia gravis • Robotics

501 - 1000

💰 $58M Venture Round on 2023-01

Description

• Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), site binder contents, etc. • Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs • Responds to sites’ regulatory board requests for protocol and ICF clarification as needed • Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment • Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews • Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites • Maintains regular communication with study sites to ensure protocol/GCP compliance, assesses subject accrual rates, and responds to sponsor requests • Conducts remote review of data entered on electronic Case Report Forms (eCRFs) • Works closely with field CRAs and data management to resolve queries on discrepant data • Assists with efforts to recruit investigative sites to participate in clinical studies • Complies with ICH GCP guidelines, FDA regulations, and company SOPs • Participates in internal, client/sponsor, scientific, and other meetings as required • Manages and resolves conflicting priorities to deliver on commitments • Performs additional duties as assigned

Requirements

• BS/BA from an undergraduate program or equivalent experience • 1-2 years of experience in clinical research • Proven ability to be careful, thorough, and detail-oriented • Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment • Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills • Self-starter who thrives in a collaborative, yet less structured team environment • Ability to problem-solve unstructured or ambiguous challenges • Strong command of English, both written and verbal • Excellent communication and interpersonal skills with customer service orientation • Proficient with MS Office Suite, particularly Word and Excel • Permanent authorization to work in the U.S.

Benefits

• professional development • global travel • flexible work programs • more