Lead Clinical Research Associate

🔥 44 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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UBC

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

UBC is a company dedicated to improving patient outcomes by connecting specialty therapies to patients in need. They provide modern and customized solutions focusing on access, safety, and evidence generation for biopharmaceutical products. UBC specializes in evidence development, risk management, and patient access, utilizing real-world data and innovative technologies to optimize the healthcare journey and ensure effective medication use.

📋 Description

• Provide clinical project oversight and support to the project management team • Oversee and manage clinical monitoring and site management activities in accordance with ICH/GCP, CFR guidelines, regulations, and SOPs • Oversee day-to-day clinical operations of US, European, and/or multinational global projects from start-up through close-out • Review and approve monitoring reports and letters • Lead and assist with project-specific training • Ensure visit scheduling, track and report site-visit adherence, and escalate issues • Oversee issues, actions, and protocol deviations for timely resolution • Serve as primary liaison for monitoring issues and escalate to PM or EDO Manager when appropriate • Assist with sponsor, project team, and UBC meetings • Act as backup for PM and primary contact for UBC/sponsor interaction when required • Collaborate with PM on resourcing, cost variances, out-of-scope management, and revenue recognition • Coordinate site assignments with PM and EDO Manager • Monitor clinical operations against plans, SOPs, and KPIs • Assist with creation and maintenance of project-specific documents • Maintain audit-ready eTMF, CTMS, and project-specific systems • Mentor and support the project team • Review, submit, and track regulatory and ethics applications as required • Oversee site contract negotiation activities as required • Perform site monitoring as needed • Review and oversee study feasibility assessments • Assist with vendor CRA management • Travel up to 30% may be required • Perform other duties as assigned

🎯 Requirements

• Bachelor’s degree in Health Care/Life Science preferred or equivalent industry experience • Minimum of 5+ years of site management experience required • Preference for 2 years field monitoring experience • Knowledge and understanding of the local country laws applicable to clinical trials and observational studies • Proficient in the operational methodologies of clinical trials and observational studies • Thorough knowledge of medical terminology, ICH/GCP and UBC SOPs • Excellent written and verbal communication skills in English and local language • High attention to detail • Excellent critical thinking and resolution skills • Leadership, organizational, communication, time management and interpersonal skills • Proven skills with CTMS, eTMF, EDC, Microsoft Office, basic computer software and sponsor specific systems • Ability to work independently and within a cross-team environment • Ability to coordinate monitoring project activities at local, national, and international studies

🏖️ Benefits

• Remote opportunities • Competitive salaries • Growth opportunities for promotion • 401K with company match • Tuition reimbursement • Flexible work environment • Discretionary Time Off • Paid Holidays • Employee assistance programs • Medical, Dental, and vision coverage • HSA/FSA • Telemedicine (Virtual doctor appointments) • Wellness program • Adoption assistance • Short term disability • Long term disability • Life insurance • Discount programs

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