Site Management Associate II

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Regular Research & Clinical Remote, US

3 days ago Requisition

As a pharmaceutical support industry leader , UBC is devoted to empowering health solutions for a better tomorrow . We take pride in improving patient outcomes and advancing healthcare. At UBC we provide services to enhance the entire drug development process and commercialization lifecycle
- From clinical trial support to real-world evidence generation.

Embark on a rewarding career journey with UBC! Grow your career while making a meaningful impact on the world around you. UBC fosters a culture built on our Core Values being:
Collaborative, Conscientious, Curious, Consultative, and Compassionate. We believe in an inclusive workplace that fosters creativity.

If you are seeking a career that will challenge, inspire, and reward you, join us at UBC!

Job Title
: YLM
14F
- Site Management Associate II

Brief Description
:
Responsible for performing investigative site recruitment/feasibility, site project training, remote monitoring visits, remote clinical data monitoring and resolution, site progress status tracking, in-house site management, routing documents for filing in eTMF, and other duties in accordance with Sponsor and/or UBC requirements. Performs essential document collection and review for site start up and initiation in compliance with project specifications and applicable SOPs with adherence to FDA Regulations, ICH/GCP guidelines and good documentation practices.

Specific Job Duties
:

• Perform investigative site feasibility, including evaluation of site interest, subject population, facilities, staff qualifications, and overall capability to conduct the study.
• Conduct study feasibility assessments with sites, including review of country-specific requirements.
• Prepare, distribute, collect, evaluate, and approve essential documents required for competent authority and/or IRB/EC submission.
• Submit essential documents to Competent Authorities;
  Central and Local IRBs/ECs; manage site submissions and ensure approvals are received and documented.
• Conduct essential document packet submissions for site activation and/or drug release.
• Consult with PM/designee on the creation of project plan documents (EDRP and Site Management and Monitoring Plan).

• Maintain regular contact with assigned sites per study requirements and ensure positive site relationships.
• Evaluate site performance and verify compliance with ICH/GCP, regulatory requirements, subject safety, and privacy laws.
• Manage site inventory of study supplies and investigational product, ensuring adequate stock and confirming return/destruction at study close‑out.
• Ensure follow‑up of site issues and action items within required timelines.
• Confirm that sites notify IRB/EC of study closure and final subject status.
• Escalate potential misconduct, fraud, or non‑compliance to Project Management, Functional Management, and Quality Assurance.

• Perform remote monitoring visits in accordance with project‑specific plans and UBC/Sponsor SOPs.
• Provide comprehensive site training on protocol, regulatory compliance, study procedures, andrequiredsystems including vendor platforms.
• Provide guidance on protocol compliance and subject eligibility.
• Complete site monitoring reports and follow‑up letters requiring minimal correction.
• Enters site visits, site monitoring reports, follow‑up letter sent dates and site contacts into the Clinical Trial Management System (CTMS).
• Review electronic data, confirm protocol deviations are reported appropriately, and collaborate with sites…