Clinical Trial Associate (Part-Time, 20 hours/week)
Potential for Full-Time Conversion
[Position Overview]
The Clinical Trial Associate (CTA) plays a critical role in supporting the execution of Voronoi’s early-phase oncology clinical programs. Reporting to the Clinical Operations Lead, the CTA will collaborate closely with Clinical Operations, Regulatory, Quality, and external CRO/vendor partners to ensure inspection-ready, high-quality study conduct in accordance with ICH/GCP and internal SOPs. This is a part-time (20hours/week) role with required in-office presence two days per week. Strong performance and growing organizational needs may lead to full-time conversion.
[Key Responsibilities]
Study Coordination & Communication
- 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.
Documentation & Regulatory Support
- 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.
Tracker & System Management
- 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.
Study Operations Support
- Coordinate the preparation ofinvestigator 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.
Quality & Compliance
- 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.
Process Improvement
- 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.
[Qualifications]
Education
- BA/BS degree in Life Sciences, Nursing, or a related scientific discipline preferred.
Experience (Preferred)
- Experience or internship in clinical research, clinical operations, or clinical trial documentation strongly
preferred.
- Familiarity with IRB/IEC processes, ICF management, TMF/eTMF, or CTMS systems is a plus.
- Experience supporting oncology and/or early-phase studies is highly desirable.
Skills & Abilities
- Strong understanding of ICH/GCP and regulatory compliance in clinical trials.
- Exceptional organizational skills with the ability to manage multiple tasks and priorities simultaneously.
- Strong communication and interpersonal skills across internal teams, sites, and vendors.
- High attention to detail with a strong commitment to documentation quality and accuracy.
- Proficiency in MS Office and comfort using clinical systems/tools.
- Strong problem-solving skills and ability to anticipate needs.
Other Information
- The position is part-time at 20 hours per week.
- Candidates eligible to work in Boston are preferred.
- This is a remote role with a required in-office presence two days per week.
- High performing part-time CTAs may be considered for full-time conversion as the organization scales.
Clinical Trial Associate (Part-Time, 20 hours/week)
Potential for Full-Time Conversion
[Position Overview]
The Clinical Trial Associate (CTA) plays a critical role in supporting the execution of Voronoi’s early-phase oncology clinical programs. Reporting to the Clinical Operations Lead, the CTA will collaborate closely with Clinical Operations, Regulatory, Quality, and external CRO/vendor partners to ensure inspection-ready, high-quality study conduct in accordance with ICH/GCP and internal SOPs. This is a part-time (20hours/week) role with required in-office presence two days per week. Strong performance and growing organizational needs may lead to full-time conversion.
[Key Responsibilities]
Study Coordination & Communication
- 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.
Documentation & Regulatory Support
- 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.
Tracker & System Management
- 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.
Study Operations Support
- Coordinate the preparation ofinvestigator 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.
Quality & Compliance
- 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.
Process Improvement
- 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.
[Qualifications]
Education
- BA/BS degree in Life Sciences, Nursing, or a related scientific discipline preferred.
Experience (Preferred)
- Experience or internship in clinical research, clinical operations, or clinical trial documentation strongly
preferred.
- Familiarity with IRB/IEC processes, ICF management, TMF/eTMF, or CTMS systems is a plus.
- Experience supporting oncology and/or early-phase studies is highly desirable.
Skills & Abilities
- Strong understanding of ICH/GCP and regulatory compliance in clinical trials.
- Exceptional organizational skills with the ability to manage multiple tasks and priorities simultaneously.
- Strong communication and interpersonal skills across internal teams, sites, and vendors.
- High attention to detail with a strong commitment to documentation quality and accuracy.
- Proficiency in MS Office and comfort using clinical systems/tools.
- Strong problem-solving skills and ability to anticipate needs.
Other Information
- The position is part-time at 20 hours per week.
- Candidates eligible to work in Boston are preferred.
- This is a remote role with a required in-office presence two days per week.
- High performing part-time CTAs may be considered for full-time conversion as the organization scales.