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Site Management Associate II

đź•’ August 8

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚫👨‍🎓 No degree required

đź‘» Ghost score 31%

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Logo of UBC

UBC

1001 - 5000 employees

Founded 2003

🏥 Healthcare

đź’Ľ 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.

đź“‹ Description

• Perform investigative site feasibility, qualification, and start-up activities • Evaluate site interest, subject population, facilities, staff qualifications, and study capabilities • Prepare, collect, evaluate, approve, and submit essential documents to competent authorities and IRB/ECs • Manage site submissions, approvals, activation, and drug-release documentation • Maintain regular contact with assigned sites and oversee site relationships • Evaluate site performance and compliance with ICH/GCP, regulatory requirements, subject safety, and privacy laws • Manage study supplies and investigational product inventory • Follow up on site issues and action items and escalate misconduct, fraud, or non-compliance • Perform remote monitoring visits according to project plans and SOPs • Train sites on protocols, regulatory compliance, study procedures, and vendor platforms • Complete monitoring reports and follow-up letters • Enter site visits, monitoring reports, follow-up dates, and contacts into CTMS • Review electronic data, protocol deviations, EDC/eCRF data, SAE reporting, and query resolution • Maintain an audit-ready Trial Master File and manage essential document collection, filing, and quality review in eTMF • Track milestones, enrollment, and study metrics in eTMF, CTMS, and project dashboards • Provide verbal and written updates to internal and external stakeholders • Support sites in meeting enrollment targets • Participate in project, department, and management meetings • Lead, mentor, and train junior staff; provide performance feedback • Analyze policies and procedures, develop solutions, and recommend improvements

🎯 Requirements

• 3+ years of relevant clinical research experience required • Bachelor's degree or relevant work experience in clinical research/health related industry preferred • Excellent written and verbal communication skills required • Strong Microsoft Office skills (Outlook, Word, and Excel) required • Aptitude in learning new computer systems required • Ability to be flexible and multitask required • Demonstrates problem solving and leadership skills • Basic medical terminology or knowledge desired • Knowledge of clinical research, industry standards, and UBC systems/workflows • Ability to lead, mentor, and train SMA or junior staff as assigned

🏖️ Benefits

• Remote opportunities • Competitive salaries • Growth opportunities for promotion • 401K with company match • Tuition reimbursement • Flexible work environment • 20 days PTO • 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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