Clinical Trial Associate

Equillium (www.equilliumbio.com) is a clinical stage biotech company focused on developing novel therapies for severe and life threatening autoimmune and inflammatory diseases. Its lead program, EQ001, is a first-in-class anti-CD6 mAb that targets a novel co-stimulatory pathway involved in the activation, proliferation, differentiation and trafficking of T effector cells in autoimmune and inflammatory diseases. Equillium is currently conducting clinical studies in GVHD, lupus nephritis, and Asthma.

The Clinical Trial Associate (CTA) is responsible for assisting with clinical operations activities or projects and will interact and collaborate with the Clinical Operations team and may interact with study vendors and/or clinical study sites. The CTA supports the timely conduct of clinical studies per study protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of Clinical Trials.

Essential Duties & Responsibilities:

• Support relevant aspects of Clinical Trials from initiation, planning, execution, maintenance through close-out.
• May collaborate/interact with CROs, vendors and clinical study sites.
• Support site activation, patient enrollment and data collection in accordance with study timelines and objectives.
• May collect and/or review and assess study site documents required for site activation and investigational product release.
• May track data around site monitoring visit scheduling and reporting.
• May track visit reports for: Qualification Visits, Initiation Visits, Interim Monitoring Visits, and Closeout Visits on an ongoing basis and reconcile with site status and study needs.
• Schedule, set- up, draft and distribute meeting minutes for internal study team and any relevant vendor meetings, as applicable.
• May support tracking and review of invoices from vendors/sites in accordance with the agreements/budgets.
• May draft or review clinical study documents such as: site documents, study guides, site and pharmacy binders, patient diaries/questionnaires, slide presentations and forms or templates.
• May build and ship study site supplies such as site binders, lab kits, and other supplies.
• May support the planning of Investigator Meetings and/or Site and CRA trainings or calls.
• May manage the oversight/tracking of sample collection (i.e., tissue samples, lab samples, scans, PK samples, etc.).
• May complete data/query review and tracking to assist with vendor oversight
• May track vendor deliverables per project plan to actual completion of those tasks.
• Will ensure all relevant documents are uploaded into the Electronic Trial Master File (eTMF).
• Will manage the exchange of TMF documents with external service providers, as applicable.
• Will maintain eTMF metrics and results of eTMF reviews.
• Will perform periodic reviews and QC of the Trial Master File and manage findings through completion.
• Will provide applicable essential documents to Regulatory for submission to the FDA.
• Will serve as a liaison and resource for study sites.
• Additional Clinical Operations activities may be assigned as appropriate.
• Travel may be required to carry out responsibilities.
• May participate in the development, review and implementation of departmental SOPs and processes.

Job Requirements:

Education:

• Bachelors or equivalent experience in a scientific or health care field preferred.

Experience:

• Minimum of 1 year of relevant CTA experience in a biotechnology or pharmaceutical company required.
• Clinical operations experience at a small or mid-size company.
• Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities.
• Knowledge of ICH/GCP guidelines, regulatory requirements and Clinical Trial operations.
• Excellent verbal and written communication skills.
• Ability to collaborate and respond to changing circumstances and needs.
• Hybrid in office environment

Skills and Attributes:

• Attention to detail
• Excellent time management and organizational skills
• Proven ability to manage and prioritize multiple tasks and associated deadlines
• Exceptional communication and interpersonal skills
• Strong computer literacy, including Microsoft Office suite and eTMF software, such as Veeva
• Flexibility to adapt in a cross-functional and dynamic, “start-up” type environment
• Extensive experience in successfully supporting the operations of domestic and international Clinical Trials.
• Travel Requirement: may travel domestically, as needed.

Equal Opportunity Employer