Clinical Trial Specialist II

This is a fully remote position, open to applicants in United States.

📋 Description

• Accountable for conducting investigative site recruitment and feasibility assessments, training for site projects, remote monitoring and resolution of clinical data, tracking site progress, managing in-house site operations, filing documentation, and performing other tasks in line with Sponsor and/or UBC standards.

• Responsible for the collection and review of essential documents for site initiation, ensuring compliance with project specifications and relevant SOPs, while adhering to FDA Regulations, ICH/GCP guidelines, and best practices in documentation.

• Exhibits the capability to effectively lead and mentor CTS personnel, undertake high-level responsibilities as assigned by the Project Manager or Functional Manager, and identify as well as manage risks appropriately.

• Oversee Regulatory and Institutional Review Board (IRB) activities: Prepare, distribute, collect, assess, and authorize regulatory documents necessary for compliance and IRB submissions.

• Perform site management activities: Assess sites to gauge interest, sufficient subject population, available facilities, staff qualifications, and capabilities to execute a study.

• Nurture site relationships to guarantee positive interactions through regular communication with sites.

• Ensure compliance with subject safety reporting regulations: Evaluate the consistency, quality, and timeliness of serious adverse events reported by the site and submissions to the IRB to ensure appropriate dissemination of subject safety information.

• Develop and maintain Trial Master Files (TMF) and guarantee the TMF is ready for audits by Regulatory Authorities and Clients.

⛳️ Requirements

• A Bachelor's degree or equivalent relevant work experience is necessary.

• A minimum of 2 years of pertinent clinical research experience is required.

• Strong written and verbal communication skills are essential.

• Proficiency in Microsoft Office applications (Outlook, Word, and Excel) is needed.

• Ability to learn new computer systems is required.

• Flexibility and the ability to multitask are necessary.

• Basic knowledge of medical terminology is preferred.

🏝️ Benefits

• Opportunities for remote work.

• Competitive salary packages.

• Opportunities for career advancement.

• 401K plan with company matching*

• Tuition reimbursement programs.

• Flexible work environment.

• 20 days of paid time off (PTO).

• Paid holidays.

• Employee assistance programs.

• Medical, dental, and vision insurance.

• Health Savings Account (HSA) and Flexible Spending Account (FSA).

• Telemedicine services (virtual doctor appointments).

• Wellness programs.

• Adoption assistance.

• Short-term disability coverage.

• Long-term disability coverage.

• Life insurance benefits.

• Discounts through various programs.