Clinical Trial Assistant
- Job Title
- Clinical Trial Assistant
- Job ID
- 27698729
- Work Hybrid
- Yes
- Location
- Boston, MA 02108
- Other Location
- Description
-
Description: Aveo Oncology is looking for an experienced Clinical Operations professional. The Clinical Trial Assistant will report to the Vice President or Associate Director, Clinical Operations. The role is primarily responsible for supporting close interactive oversight to ensure exceptional execution of AVEO Oncology clinical studies. The Clinical Trial Associate will also be accountable for participating in departmental efficiency initiatives in support of department excellence.
The Clinical Trial Assistant will support monitoring clinical studies across geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), regulatory authority guidance and directives such as Food and Drug Administration (FDA), and International Conference on Harmonization (ICH) guidelines.
The Clinical Trial Assistant will support ensuring quality data for all clinical trials. The Clinical Trial Assistant will support the interactions with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines so that data is suitable for regulatory submissions and publications. The Clinical Trial Assistant will also support metrics-based assessments to measure departmental and 3rd party performance on a quarterly basis to meet corporate goals. The Clinical Trial Assistant will also assist with troubleshooting routine site inquiries.
Outside interfaces may include other Aveo Oncology business groups and subsidiaries in the US and abroad, governmental, academic, community and industry organizations.
The Clinical Trial Assistant will not have assigned direct reports.
Good written and verbal communication skills and attention to detail are required and are equally important. The ideal candidate for this role is an individual who is excited to take on new challenges in a dynamic environment. To be successful, the candidate is committed to collaboration and a data driven approach to align with the team’s brand and culture.
Responsibilities
Study Management and Leadership
- Collaborate closely with Clinical Team in support of study execution
- Support planning and logistics for internal and external meetings and preparation of agendas, meetings, and meeting minutes
- Support oversight of site compliance with study protocol
- Support and maintain metrics-based tools to assess departmental and 3rd party performance on a quarterly basis to meet corporate goals
- Support adherence to internal procedures for study planning, study conduct, close out and reporting
- Support all inspection readiness and quality initiatives for assigned studies
- Support tracking of operational study timelines and monitor operational performance metrics through the life of the study, support issue resolution
- Assist in the creation and review of informed consents, case report forms, study operations manuals, monitoring tools, and other study-related materials
- Support site level progress ensuring timely data collection, source document verification, and query resolution
- Develop and maintain audit-ready clinical trial documentation in the TMF: Manage and track regulatory/IRB/EC documentation,
- Contact clinical sites and/or CROs to complete study files and regulatory document collections
- Ensure timely safety reporting at assigned investigative sites
- Assist in the process of executing clinical trial and vendor agreements
- Assist with study document filing
Knowledge Management/People Management
In in support of goals, the Clinical Trial Assistant will:
- Assist in updating SOPs
- Support GCP and operational systems training
- Bachelor's Degree in a Life Sciences
- Minimum of 3 years experience in clinical operations methods and processes in industry setting required
- At least 2 years oncology monitoring experience preferred
- Strong understanding of ICH, GCP, and relevant regulatory requirements
- Good communication skills and proficiency with Microsoft Outlook, Excel, Word and PowerPoint
- Familiarity with setting up and maintaining trial master files and performing file audits preferred
- Proactive and able to work independently
- Ability to prioritize and multi-task with attention to detail
- Strong organizational skills
- Ability to travel up to 20% In-house office position that may require travel (global)
About AVEO
On January 20, 2023, AVEO Oncology was acquired by LG Chem, Ltd. (“LG Chem”), expanding LG Chem’s oncology portfolio. AVEO now operates as an LG Chem company with a shared mission of providing innovative solutions to improve cancer patients’ lives. The combined synergy of AVEO and LG Chem will result in a global oncology organization with a robust portfolio of innovative products and deep capabilities from discovery to clinical, biologics manufacturing and U.S. commercialization, at a scale capable of delivering on its mission to improve the lives of patients with cancer. Bringing together AVEO and LG Chem provides significant momentum for AVEO to evolve to the next level, a global top 20 oncology leader in the next 5 years.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
