临床试验专员II

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!

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 Oversight

• Maintain Trial Master File (TMF) in compliance with FDA regulations, ICH/GCP, and applicable local laws ensuring the TMF is audit ready.

• Manage ongoing collection,timely filing and quality review of essential documents for TMF submission.

• Preserve security and integrity of study documents and ensure audit readiness.

• Ensure site documents are present in TMF at the appropriate status, all quality issues are resolved, and site lifecycle is updated prior to TMF transfer and archival.

• Track andmaintain essential document collection within eTMF systems.

Study Metrics, Tracking & Reporting

• Track milestones,enrollment status, and study metrics in applicable systems (eTMF, CTMS, Project-Specific Dashboards, etc); provide regular verbal and written updates to internal and external stakeholders.

• Support sites in meeting enrollment targets to satisfy contractual obligations.

• Generate and review project‑specific metrics as needed.

Cross‑Functional Collaboration & Meetings

• Participate in project team meetings, department meetings, and 1:1 meetings with management.

• Assist with other tasks as assigned.

Job Duties Specific to SMA II

• Demonstrate ability to lead, mentor, and train SMA or junior staff as assigned.

• Provide performance feedbackregardingdepartmental goals and objectives.

• Develop solutions to a variety of moderate to complex issues,analyze policies and procedures, and recommend improvements.

• Demonstrate thorough knowledge in clinical research, industry standards, and UBC systems/workflows.

Supervisory Responsibility: N/A

Desired Skills and Qualifications:

• Bachelor's degree or relevant work experience in clinical research/health related industry preferred.

• 3+ 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.

• Demonstrates problem solving and leadership skills

• Basic medical terminology or knowledge desired.

Benefits:

At UBC, employee growth and well-being are always at the forefront. We offer an extensive range of benefits to ensure that you have everything you need to thrive personally and professionally.

Here are some of the exciting perks UBC offers:

• 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

UBC is proud to be an equal opportunity employer and does not discriminate because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state, or local protected class. We are committed to a diverse, equitable and inclusive culture that fosters respect for each other, our clients, and our patients.

Originally posted on Himalayas