Senior Clinical Research Associate

🕒 August 11

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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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

• Monitor clinical trials and observational studies to ensure protocol adherence, site activity management, and data collection and integrity • Ensure sites conduct studies and report study data according to regulations, guidelines, and sponsor requirements • Perform remote and on-site monitoring according to project timelines • Schedule travel and submit expense reports according to company policies • Attend project, department, and manager meetings • Complete site monitoring reports and letters with minimal corrections • Follow up on site issues and action items within required timelines • Enter site visits, monitoring reports, follow-up dates, and site contacts into the CTMS • Monitor EDC data entry and assist sites with eCRF resolution • Review Investigator Site Files and perform Investigational Product reconciliation • Maintain regular contact with assigned sites • Complete SOP reviews, training assessments, and documentation • Mentor, train, and assess junior CRAs • Assist with CRA, departmental, and sponsor-specific training presentations • Assist the Project Manager and Lead CRA with additional tasks • Complete site management and monitoring activities according to project plans and timelines • Perform other assigned duties

🎯 Requirements

• Bachelor’s degree – Life Science preferred, or equivalent years of industry and clinical research experience • Minimum of 36 months of on-site monitoring experience, including site selection, initiation, management, and monitoring activities • Comprehensive knowledge of medical terminology and regulatory guidelines • Excellent critical thinking and resolution skills • Excellent written and verbal communication skills in English and local language, as applicable • Experience working in clinical trials and observational studies preferred • Experience and familiarity with CTMS, eTMF, EDC, and Microsoft Office applications • Proven ability to deliver highly accurate work and adhere to deadlines in a fast-paced environment • Travel up to 80% required in the North American region

🏖️ Benefits

• Remote opportunities • Competitive salaries • Growth opportunities for promotion • 401K with company match • Tuition reimbursement • Flexible work environment • Discretionary PTO (Paid 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