Clinical Trial Specialist II

About this role

As a pharmaceutical support industry leader, UBCis devoted toempowering health solutions for a better tomorrow. We takeprideinimprovingpatient outcomes andadvancing healthcare.At UBCwe provide services to enhance the entire drug development process and commercialization lifecycle - From clinical trial support to real-world evidence generation.

Embark on a rewardingcareer journey with UBC! Growyour career while making a meaningfulimpacton theworldaround you.UBCfosters a culture built on our Core Values being: Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in aninclusive workplacethat fosters creativity.

If you are seeking a career that willchallenge, inspire,andrewardyou, join us atUBC!

Title: YLM03F – Clinical Trial Specialist II

Brief 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.

Specific job duties:

• 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.

Desired Skills and 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.

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