Senior Clinical Trial Assistant

Position: (Sr.) Clinical Trial Assistant, Clinical Operations

Location: Boston, MA

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 3^rd 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 3^rd 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

* Maintains and reviews various study-related tracking systems to determine and report status of clinical trial documents (i.e., distribution, status, retrieval of such documents as protocol, IB, etc.)

* Support Clinical Project Manager and Clinical Research Associate for meeting minutes as requested

* Support study team in tasks such as presentations, mailings to sites, assembly and distribution of Investigator Site Files, newsletters and handling of study documents, copying and filing, correspondence. The CTA will maintain site contact lists, trackers, etc.

* Support the Clinical Project Manager for review of invoices.

* Generate mass mailings upon request of the Clinical Project Manager.

* Perform administrative tasks to support team members with clinical trial execution as needed.

CRO, 3rd Party Vendor Management and Oversight for assigned studies

* Support tracking of operational study timelines and monitor operational performance metrics through the life of the study, support issue resolution

* Support Biosample tracking from sites to central lab sample management to central analytical lab.

* 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, IND Safety Letter distribution, Confidentiality Disclosure Agreements, and other clinical trial documents

* Contact clinical sites and/or CROs to complete study files and regulatory document collections to ensure TMF documents are filed in TMF in a timely manner

* 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

Education Qualifications (from an accredited college or university)

* Bachelor's Degree in a Life Sciences

Experience Qualifications

* 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

Travel

* Ability to travel up to 20% In-house office position that may require travel (global)

About AVEO

AVEO is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. AVEO's strategy is to focus its resources toward development and commercialization of its product candidates in North America, while leveraging partnerships to support development and commercialization in other geographies. AVEO's lead candidate, FOTIVDA (tivozanib), received U.S. Food and Drug Administration (FDA) approval in March 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the EUSA territory for the treatment of adult patients with advanced RCC. AVEO has previously reported promising early clinical data on ficlatuzumab (anti-HGF IgG1 mAb) in head and neck squamous cell carcinoma (HNSCC), pancreatic cancer and acute myeloid leukemia, and expects to make a go/no-go decision on the initiation of a pivotal Phase 3 study of ficlatuzumab in HPV negative HNSCC following feedback from the FDA. AVEO's pipeline of product candidates also includes AV-380 (anti-GDF15 IgG1 mAb). AVEO has previously reported the acceptance of its investigational new drug application in the U.S. for AV-380 and its initiation of a Phase 1 clinical trial for the potential treatment of cancer cachexia. AVEO's earlier stage pipeline includes monoclonal antibodies in oncology development, including AV-203 (anti-ErbB3 mAb) and AV-353 (anti-Notch 3 mAb). AVEO is committed to creating an environment of diversity and inclusion.

FOTIVDA (tivozanib) is an oral, once-daily, differentiated vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability.^1,2

AVEO's Guidelines and Practices are not intended to create a contract, express or implied, and nothing herein changes or alters your status as an "at-will" employee. These Guidelines and Practices should not be considered all inclusive, but rather a set of guidelines. As such, they are subject to amendments, deletions and changes as required by the needs of the business.