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Avalyn Pharma · 5 days ago

Clinical Trial Associate

United States

Full-time

Remote

Entry Level

$90K/yr - $125K/yr

2+ years exp

Avalyn is a biopharmaceutical company focused on developing inhaled therapies for rare respiratory diseases. The Clinical Trial Associate will provide administrative and project support for clinical research studies, assisting with study start-up, ongoing conduct, and close-out activities while collaborating with various teams and partners.

BiopharmaBiotechnologyMedicalPharmaceutical

Responsibilities

Support TMF related activities (sending / tracking Avalyn vendor documents to CRO TMF, TMF QC and reconciliation (through life of the trial and final reconciliation) Including conducting TMF audits based on the timing outlined in the applicable study plans communicating issues identified to the CRO and tracking resolution of the identified issues

Create and maintain a SharePoint study file organization structure; build a file folder format consistent with TMF reference model to use consistently across all trials

Assist with study start-up, maintenance, and close-out activities in collaboration with CROs, vendors, and internal cross-functional teams

Responsible for coordination of meetings and generate meeting minutes

Will assist in building Smartsheet or similar workspaces to house various study specific trackers allowing for a central location

Responsible for supporting Data Review, identifying gaps/missing data, outliers, etc) to ensure accuracy of data. Track and report status of issues to resolution, escalating when appropriate

Support GCP compliance and inspection readiness activities by ensuring study documentation is complete, accurate, and well organized

Assist with internal audits, inspection preparation activities, and responses to audit findings as needed

Qualification

Clinical OperationsTrial Master File (TMF)ETMF systemsData ReviewMicrosoft OfficeAttention to detailOrganizational skillsTime managementCommunication skillsCollaboration

Required

Minimum of Bachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related field (or equivalent relevant experience)

2+ years of experience in Clinical Operations, Clinical Research, or a related clinical trial support role (industry or CRO)

Working knowledge of clinical trial documentation and Trial Master File (TMF) requirements including the CDISC TMF reference model

Experience supporting TMF activities, including document collection, filing, tracking, and basic QC

Familiarity with electronic TMF (eTMF) systems and document management best practices

Experience with TMF related activities (sending / tracking Avalyn vendor documents to CRO TMF, TMF QC (set a frequency through life of the trial and final recon)

Ability to build, maintain, and update study trackers (e.g., Excel, Smartsheet, or similar tools)

Strong attention to detail with the ability to identify missing, inconsistent, or incomplete information

Excellent organizational, time management, and prioritization skills

Strong written and verbal communication skills, including the ability to document meeting minutes clearly and concisely

Ability to work collaboratively, as well as independently. with cross-functional teams, CROs, and external vendors

Must be familiar with ICH GCP and appropriate regulations

Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook)