Clinical Trial Specialist II

🕒 4 days ago

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UBC

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

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

• Responsible for performing investigative site recruitment/feasibility, site project training, remote clinical data monitoring and resolution, site progress status tracking, in-house site management, documentation filing, and other duties in accordance with Sponsor and/or UBC requirements. • Performs essential document collection and review for site start up and initiates in compliance with project specifications and applicable SOPs with adherence to FDA Regulations, ICH/GCP guidelines and good documentation practices. • Demonstrates ability to successfully lead and mentor CTS staff, take on high level tasks as delegated by Project Manager/Functional Manager, and escalate and mitigate risk as appropriate. • Manage Regulatory and Institutional Review Board (IRB) Activities: Prepare, distribute, collect, evaluate, and approve regulatory documents required for regulatory compliance and IRB submission. • Conduct Site Management Activities: Evaluate sites to determine interest, adequate subject population, facilities, staff and qualifications to conduct a study. • Manage site relationships to ensure positive interactions through routine site contact. • Ensure sites meet subject safety reporting regulations: subject safety information is disseminated appropriately by evaluating consistency, quality and timeliness of serious adverse events reported by the site and submission to the IRB. • Create and maintain Trial Master Files (TMF) and ensure Regulatory Authority and Client audit readiness of TMF.

🎯 Requirements

• Bachelor's degree or relevant work experience required • 2+ years of relevant clinical research experience required • 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 • Basic medical terminology or knowledge desired.

🏖️ 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