Clinical Research Associate

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🏄 California, Colorado, +7 more states – Remote

🏄 California – Remote ⛰️ Colorado – Remote 🏛️ District of Columbia – Remote 🌺 Hawaii – Remote 🌽 Illinois – Remote 🏖️ New Jersey – Remote 🗽 New York – Remote 🍂 Massachusetts – Remote ☕ Washington – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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WEP Clinical

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2008

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🧬 Biotechnology

Pharmaceuticals • Healthcare Insurance • Biotechnology

WEP Clinical is a Pharmaceutical Services Provider that specializes in Drug Development Programs, Treatment Access Solutions, and Market Access and Commercialization. The company focuses on providing critical support throughout the entire drug development and commercialization journey, helping sponsors advance their medicines and improve patient access. WEP Clinical offers services such as clinical trial services, expanded access programs, post-approval named patient programs, and market access consulting, ensuring that much-needed therapies reach patients worldwide.

📋 Description

• Schedule and perform on-site or remote monitoring visit activities, inclusive of the following study visit types: Site Initiation Visit (SIV), Interim Monitoring Visit (IMV) / Routine Monitoring Visit (RMV), and Close Out Visit (COV). • Contribute to the development of protocols, study tools, materials, and documentation for clinical sites. • Provide feedback to assist sites with resolution of detected deficiencies and corrective action needed. • Review site-level investigational drug accountability and safety event documentation. • Review and verify patient files and records, informed consent, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identify deficiencies; provide training and/or initiate corrective action as required. • Identify, document, track, and report site protocol deviations and violations as defined within the EAP Monitoring Plan. • Manage query resolution. • Provide mentoring, training, and co-monitoring of junior team members. • Assist in the development of applicable WEP Clinical Standard Operating Procedures. • Develop applicable document templates, including (but not limited to), Monitoring Plans, Monitoring Visit Reports, Confirmation Letters, Follow-Up Letters, and Query Logs. • Complete, review, and/or submit monitoring reports and query logs. • Address protocol or monitoring-related questions received from clinical sites for assigned programs.

🎯 Requirements

• Approximately 1+ years of on-site and remote monitoring experience; The level/title will be determined as part of the interview process • BA/BS, preferably in a life science, nursing, pharmacy or related field • Clinical background preferred • Broad range of therapeutic experience • High organizational and logistics skills to ensure effective management of multiple sites and protocols within timeframes and on budget • Superior written and verbal communication skills • Computer literacy, including proficiency in MS Office and use of EDC systems • Willingness to travel up to 80%

🏖️ Benefits

• Medical, dental, and vision insurance • FSA, HSA • Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance • Group short-term and long-term disability insurance • Group Life Insurance • 401K safe harbor plan and company match • Paid vacation, holiday, sick and volunteer time • Paid maternity & paternity leave