Avalo Therapeutics
Clinical Trial Associate
Chesterbrook, PA · Full-time
Sponsorship not specifiedDetected 14 days ago
GCPExcelLogisticsClinical TrialsClinical ResearchResearchMicrosoft OfficeSharePoint
About the role
- We share a commitment to teamwork, passion for science, and dedication to patients suffering from acute and chronic inflammatory disorders.
- Our collective expertise in discovery, development, and regulatory approvals is evidenced in our strong individual track records of advancing multiple therapeutic programs to successful commercialization.
- This is a 6-month contract with potential conversion to full time employment.
Responsibilities
- Create and/or review study plans, specification documents, materials, and tools.
- Support outsourced activities to Clinical Research Organizations (CROs) and other third-party vendors for assigned activities.
- Responsible for tracking study progress in CTMS, including site activation, patient enrollment, patient status, oversight of Regulatory documents for site initiation and close out.
- Deliver and execute operational tasks, and assist in tracking study metrics, maintenance, and distribution of study trackers.
- Collaborate with clinical trial sites to develop relationships and support the collection of relevant study materials and documentation.
- Review documents for completeness, accuracy, and compliance with protocol and appropriate regulations; Identify issues and take appropriate corrective actions.
- Assist in preparing or review study-related documents (i.e., ICF, clinical trial tools, templates, training materials, manuals, study newsletters, etc.).
- Build strong professional relationships with vendors, and individuals at all cross functional levels of the organization.
- Oversee TMF Quality Review for study team; complete TMF QC for the department quarterly for each study, including collecting, reviewing, and submitting documents to the TMF.
- Support project meeting logistics such as: calendar management, room and equipment set up, collation of materials, and attendance tracking. Working with the Clinical Trial Manager, prepare meeting agendas and draft, finalize, and distribute meeting minutes.
Nice to have
- Minimum of 2-5 years of experience in a relevant field, e.g., clinical site, CRO, Sponsor or clinical trial vendor (sponsor experience preferred).
Benefits
- Bachelor's degree in life sciences or healthcare-related field.
- Education & Experience
Company info
- At Avalo (ahh-vah'-low), we are 100% focused on developing treatments for immune-mediated inflammatory diseases with large unmet needs that affect millions worldwide.
Visa & Work Authorization
- , clinical site, CRO, Sponsor or clinical trial vendor (sponsor experience preferred)
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