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Lyra Therapeutics
Watertown, Massachusetts, United States
13 hours ago
Lyra Therapeutics
Watertown, Massachusetts, United States
13 hours ago
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Lyra Therapeutics
Watertown, Massachusetts, United States
13 hours ago

Description

Lyra Therapeutics, Inc. is a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, local delivery of medications to diseased tissues not accessible with conventional therapeutic approaches. Lyra's XTreo™ platform is comprised of a biocompatible mesh scaffold, an engineered elastomeric matrix and a versatile polymer-drug complex. The company's current pipeline of therapeutics target tissues deep in the ear, nose and throat passages and are designed to deliver continuous drug therapy for up to six months following a single non-invasive, in-office administration. Lyra's lead product candidate, LYR-210, is entering Phase 3 clinical development for the treatment of chronic rhinosinusitis (CRS) as an alternative to primary sinus surgery. Lyra's second product candidate, LYR-220, is entering Phase 2 development and is designed to be an alternative to revision CRS sinus surgery and post-surgical medical management.  Headquartered in the Boston area, Lyra Therapeutics was founded by George Whitesides and Robert Langer, academic luminaries in the fields of chemistry, materials science and biotechnology.

Our team is growing and we are currently seeking an experienced Clinical Trial Associate (CTA) to join our Clinical Affairs team.  This is a key role that directly supports Clinical Operations staff, and is responsible for the planning, execution and management of in-house or outsourced clinical trials. The successful candidate will perform daily clinical trial execution activities associated with the conduct of investigational clinical studies.  They must exercise discretion and judgment in handling confidential information and will follow Food and Drug Administration (FDA) regulations, International Council for Harmonisation (ICH) guidelines, Good Clinical Practice (GCP) and company standard operating procedures (SOPs) in all tasks. Strong motivation and organizational skills are required, as well as the ability to balance changing priorities. 

Key Areas of Responsibility:

  • Key support role to Clinical Operations staff; ensure that delegated components of clinical trials are executed to expected and specified quality standards
  • Schedule and coordinate study meetings, materials and agendas; record and disseminate decisions and actions
  • Organize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
  • Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
  • Create and maintain the Trial Master File and electronic Trial Master File (TMF and eTMF) according to ICH-GCP, and company SOPs
  • Participate in drafting and coordinate review of site documents e.g. ICF, advertising materialsCollect, review, file and/or track clinical trial associated documents and regulatory packages
  • Assist in developing study plans, including Lab Manual, Clinical Monitoring Plan, Study Plan, Study Vendor Oversight Plan, Pharmacy Manual, and other. Monitor compliance to plans
  • Work directly with study sites including performing site training, review of site study packets and study files
  • Review monitoring visit trip reports
  • Assist in responding to Data Correction Forms (DCFs) and track DCF follow-up and completion activities
  • Support investigational product supply logistics
  • Responsible for study laboratory sample management, including tracking and vendor management support
  • Coordinate and track clinical trial equipment and supplies
  • May assist with site budget process
  • Review and track vendor invoices against contracts and coordinate approval
  • Assist in the creation and updating of standardized clinical trial tools, processes, and SOPs
  • Maintain and ensure all documentation is in a state of audit readiness
  • Assist in the coordination of Investigator Meetings

At Lyra, we value creativity, leadership, and collaboration.  The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable.  We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team.  For consideration, please submit cover letter and CV.

Please visit www.lyratx.com for more information. 



Requirements

  • Bachelor’s degree in life sciences or healthcare related field
  • At least 2+ year experience in clinical operations within sponsor company, CRO or investigational site strongly preferred
  • Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures in global trials
  • Experience working closely with study sites, Key Opinion Leaders (KOLs) and external vendors
  • Experience with eTMF; ability to directly apply essential document knowledge to file documents
  • Proficient in MS Excel, Outlook, Word and PowerPoint. Knowledge of MS project preferred
  • Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
  • A team player that takes initiative and has proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
  • Excellent interpersonal/team skills, strong organizational skills with professional written and verbal communication skills
  • Strong attention to quality/detail
  • Position may require some travel

Careers Information

  • Job ID: 60992244
  • Location:
    Watertown, Massachusetts, United States
  • Position Title: Clinical Trial Associate
  • Company Name: Lyra Therapeutics
  • Job Function: Clinical
  • Job Type: Full-Time
  • Job Duration: Indefinite
  • Min Education: BA/BS/Undergraduate
  • Min Experience: 2-3 Years
  • Required Travel: 10-25%

Please refer to the company's website or career descriptions to learn more about them.

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