Clinical Trial Specialist II

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Job Title : YLM14F - 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 :

Site Feasibility, Qualification & Start‑Up Activities

- 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 Managementand Monitoring Plan).

Site Management & Relationship Oversight

- 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.

Remote Monitoring Activities

- 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 for query resolution.

- Monitor EDC/eCRF data entry and assist sites with eCRF issue resolution.

- Ensure sites meet subject safety reporting regulations, including review of SAE data for consistency, quality, and timely IRB submission.

- Confirm that sites are fully compliant with subject rights and privacy protections.

Essential Document Management & TMF Oversig