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Voronoi · 4 days ago

Clinical Trial Associate (Part-Time, 20 hours/week)

Boston, MA

Part-time

Hybrid

Mid Level

3+ years exp

Voronoi is focused on early-phase oncology clinical programs, and they are seeking a Clinical Trial Associate to support the execution of these programs. The role involves coordinating study meetings, managing documentation, and ensuring compliance with regulatory standards.

BiotechnologyHealth Care

Responsibilities

Coordinate and manage internal and external study meetings, including vendor, site, and cross-functional calls

Prepare and distribute agendas, materials, and minutes, and track action items through completion

Maintain up-to-date distribution lists and ensure clear, timely communication across teams, sites, and vendors

Serve as a central point of contact to facilitate efficient and consistent information flow among all stakeholders

Serve as the ICF (Informed Consent Form) document owner, ensuring proper version control, distribution to sites, and tracking of IRB/IEC approvals

Collect and prepare study documents required for IRB/IEC submissions in collaboration with the Clinops team and as needed

Support essential regulatory document collection for start-up and ongoing study conduct (CVs, GCP certificates, licenses, financial disclosure forms, etc.)

Maintain and oversee the Trial Master File (TMF), ensuring timely filing, quality control, reconciliation, and inspection readiness per ICH/GCP and SOP requirements

Ensure all current and approved study materials (protocols, manuals, training decks, safety letters) are distributed and version-controlled

Serve as owner of internal clinical trial trackers, ensuring real time accuracy and completeness

Maintain site level contact lists, including investigators, study coordinators, and site finance teams

Maintain protocol, site, and country-specific information in internal CTMS/eTMF systems and trackers

Support updates in internal data repositories and ensure proper document availability to the study team

Coordinate the preparation of investigator site files and ensure completeness and accuracy

Assist the Clinical Operations team and other cross functional team with study operations including investigational product (IP) tracking and accountability coordination

Support logistics for study training sessions such as SIVs or small investigator meetings

Assist with vendor coordination and tracking operational deliverables

Ensure audit and inspection readiness across TMF, trackers, and study documentation

Follow SOPs, WIs, and applicable regulatory guidelines including ICH/GCP

Support preparation and responses for internal audits, external inspections, or sponsor reviews

Assist with User Acceptance Testing (UAT) for clinical systems such as eTMF or CTMS

Identify inefficiencies and propose process improvement opportunities to enhance workflow, documentation quality, and operational efficiency

Participate in the development or revision of SOPs, work instructions, and templates as needed

Qualification

Clinical Trial Associate experienceICH/GCP knowledgeRegulatory complianceMS Office proficiencyClinical systems familiarityOrganizational skillsCommunication skillsAttention to detailProblem-solving skills