Clinical Trial Specialist II

About the role

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 Clinical Trial Specialist (CTS) staff, take on high level tasks as delegated by Project Manager/Functional Manager, and escalate and mitigate risk as appropriate.

Responsibilities

• Manage Regulatory and Institutional Review Board (IRB) Activities:
  • Prepare, distribute, collect, evaluate, and approve regulatory documents required for regulatory compliance and IRB submission.
  • Submit regulatory documents to Central IRBs and manage site submissions to Local IRBs; confirm IRB approval is received and documented.
  • Conduct regulatory packet submissions to clients for site approval and drug release.
  • Create and review project planning documents including but not limited to Essential Document Review Plan (EDRP), Site Management Plan, and Project Plan.
  • Track milestones, generate study metrics, and provide written and verbal updates to internal and external customers.
  • Confirm sites have notified IRB of closure and final subject status in compliance with regulations.
  • Confirm sites have returned or destroyed study drug and other study supplies as required.
  • Train sites on their continued contractual, regulatory, and legal obligations.
• Conduct Site Management Activities:
  • Evaluate sites to determine interest, adequate subject population, facilities, staff, and qualifications to conduct a study.
  • Execute confidentiality agreement, contract, and budget negotiation with sites.
  • Provide site training and access to required systems, including vendor systems.
  • Provide site training and guidance in reference to protocol compliance.
  • Provide site training and guidance in reference to regulatory requirements and ensure compliance.
  • Manage site relationships to ensure positive interactions through routine site contact.
  • Evaluate site performance and compliance with required FDA regulations, ICH/GCP, and local laws.
  • Confirm sites are compliant with subject rights and privacy requirements.
  • 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.
  • Manage site inventory of study drug, laboratory supplies, and any other study materials to ensure sites have sufficient inventory to conduct study activities without delay.
  • Escalate potential misconduct, fraud, or noncompliance by sites to Project and Functional Management and Quality Assurance.
  • Instruct sites on study or protocol requirements and determine subject qualification based on subject eligibility parameters.
  • Track study activities, milestones, document receipt, and payment status in CTMS.
  • Participate in internal/external project team meetings.
  • Assist with other duties as assigned.
• Essential Document Management And Audit Readiness:
  • Create Trial Master Files (TMF) and maintain essential documents in compliance with FDA regulations, ICH/GCP, and local laws.
  • Manage ongoing collection and quality review of updated essential documents for submission to the TMF.
  • Preserve document security and integrity.
  • Ensure Regulatory Authority and Client audit readiness of TMF.
  • Prepare, package, and archive TMF at study closure.
• Perform Remote Monitoring Activities:
  • Verify accurate and timely electronic data entry of study subject information.
  • Review electronic data and ensure protocol deviations are reported to IRB as appropriate.
  • Collaborate with sites to achieve query resolution of electronic data.
  • Manage sites in meeting subject enrollment targets to meet contractual obligations.
  • Conduct remote monitoring visits and complete requisite visit reports.
• Facilitate Payment Distribution to Investigative Sites:
  • Contribute to project plans outlining payment strategy.
  • Evaluate data to identify milestones ensuring sites are paid according to the contract.
  • Process and distribute investigative site payments.

Qualifications

• Demonstrates ability to successfully lead, mentor, and train CTSs.
• Provides feedback on CTS performance regarding department goals and objectives.
• Proficient at CTS duties with minimal oversight.
• Exhibits good decision-making skills utilizing all available resources for determining positive outcomes.
• Develops solutions to a variety of moderate to complex issues, analyze current policies and procedures, and recommend changes as needed.
• Demonstrates thorough knowledge of clinical research, industry standards, practices, and regulations.
• Demonstrates understanding and application of UBC systems and work environment.
• Generates and reviews project-specific metrics as needed.
• May serve in a leadership/mentoring role for a specific project.
• 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