Clinical Trial Associate

Kuraoncology; Boston (MA); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Travel support

Job summary

PVH (Tommy Hilfiger/Calvin Klein) is seeking a Clinical Trial Associate to support operational execution of clinical trials from start‑up through close‑out. You will partner with Clinical Trial Leaders, study teams, CROs, and vendors to ensure trials run efficiently, compliantly, and aligned with program objectives.

The role emphasizes trial management, TMF filing, regulatory documentation, site monitoring readiness, budgeting, and cross‑functional collaboration.

Qualifications

• Ability to work in a matrix environment.
• Experience in a high-volume environment with the ability to prioritize tasks.
• Strong interpersonal skills and ability to collaborate across functions.
• Willingness and ability to travel as required.

Responsibilities

• Support clinical trial operations across all phases of the study lifecycle, ensuring milestones, deliverables, timelines, and budgets are met.
• Assist with CRO and vendor coordination and oversight, including tracking performance, deliverables, and documentation.
• Collect, track, and review investigator site regulatory documentation for completeness and accuracy.
• Manage Trial Master File (TMF) filing, maintenance, reconciliation, and inspection readiness activities in compliance with ICH‑GCP and SOPs.
• Track and maintain essential study documentation, including CTA and budget status, site and vendor payments, monitoring visits and reports, SUSARs, CAPAs, and enrollment metrics.
• Coordinate study team, vendor, and site meetings, including scheduling, agenda preparation, minute‑taking, and distribution.
• Ensure CTMS are kept current in collaboration with CTL.
• Support study start‑up, conduct, monitoring, and close‑out activities to ensure protocol adherence and regulatory compliance.
• Assist with site monitoring activities, audit and inspection preparation, and participate in audit/inspection interviews as required.
• Support ordering, tracking, and distribution of investigational product and study supplies; assist with IRT oversight and drug inventory tracking.
• Provide operational and financial support, including purchase orders, contract set‑up, invoice processing, and tracking of study budgets.
• Assist with development, review, and maintenance of study documents (protocols, ICFs, CRFs, monitoring plans, manuals).
• Review study reports and operational metrics for accuracy and quality.
• Maintain study team lists, SUSAR distribution lists, databases, and departmental systems; support training.

Skills

Matrix environment experience

High-volume environment

Interpersonal skills

Travel availability

Education

Bachelor's degree in scientific field

Job description

Job Summary

The Clinical Trial Associate (CTA) supports the operational execution of clinical trials from start‑up through close‑out. The role partners closely with Clinical Trial Leaders, study teams, CROs, and vendors to ensure trials are conducted efficiently, compliantly, and in alignment with program and company objectives.

Key Responsibilities

• Support clinical trial operations across all phases of the study lifecycle, ensuring milestones, deliverables, timelines, and budgets are met.
• Assist with CRO and vendor coordination and oversight, including tracking performance, deliverables, and documentation.
• Collect, track, and review investigator site regulatory documentation (e.g., FDA Form 1572, FDFs, CVs, medical licenses, and study‑specific documents) for completeness and accuracy.
• Manage Trial Master File (TMF) filing, maintenance, reconciliation, and inspection readiness activities in compliance with ICH‑GCP and company SOPs.
• Track and maintain essential study documentation, including CTA and budget status, site and vendor payments, monitoring visits and reports, SUSARs, CAPAs, and enrollment metrics.
• Coordinate study team, vendor, and site meetings, including scheduling, agenda preparation, minute‑taking, and distribution.
• Ensure clinical trial management systems (company and/or CRO systems) are kept current in collaboration with the Clinical Trial Leader (CTL).
• Support study start‑up, conduct, monitoring, and close‑out activities to ensure protocol adherence and regulatory compliance.
• Assist with site monitoring activities, audit and inspection preparation, and participate in audit/inspection interviews as required.
• Support ordering, tracking, and distribution of investigational product and study supplies; assist with IRT oversight and drug inventory tracking.
• Provide operational and financial support, including purchase orders, contract set‑up, invoice processing, and tracking of study budgets.
• Assist with development, review, and maintenance of study documents (e.g., protocols, ICFs, CRFs, monitoring plans, manuals).
• Review study reports and operational metrics for accuracy and quality.
• Maintain study team lists, SUSAR distribution lists, databases, and departmental systems; support study team training activities.
• Support inspection readiness, compliance activities, clinical trial insurance processes, and patient recruitment material review.
• Collaborate cross‑functionally with internal and external stakeholders to support successful trial execution.
• Perform additional duties as assigned.
• Be experienced with using different eTMF systems (e.g., Veeva Vault, etc.).
• Be accountable for the quality of own work; receive clear instruction, guidance and direction from more senior roles or solve problems of low complexity independently by identifying and selecting solutions and analyzing factual information.
• Contribute to harmonization of processes throughout Clinical Operations and use best practices to improve products or services.
• Contribute to process improvement suggestions.
• Take on additional tasks as assigned by management within a job discipline or specialized technical expertise.

Job Specifications

• Ability to work in a matrix environment.
• Experience working in a high‑volume environment while maintaining organization and the ability to prioritize tasks.
• Good understanding of the responsibilities and needs of other functions in a clinical trial.
• Reliable, conscientious, and confidential.
• Strong interpersonal skills and ability to deal with people at all levels with sensitivity and tact as well as ability to collaborate across.
• Some experience in oncology.
• Experience in CRO oversight is preferred.
• Strong organization, documentation, and communication skills with an ability to.
• Ability to travel based on assigned study needs, typically minimal travel required.
• Requires a bachelor's degree in scientific field with n