Clinical Trial Specialist II
Job 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
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