In-House Lead Clinical Research Associate (Lcra)

Description

Lyra Therapeutics, Inc. is a clinical-stage biotechnology company developing novel, integrated drug and delivery solutions for the localized treatment of patients with chronic rhinosinusitis (CRS) and otherchronic diseases. Lyra has two investigational product candidates, LYR-210 and LYR-220, in late-stagedevelopment for CRS, a highly prevalent inflammatory disease of the paranasal sinuses which leads todebilitating symptoms and significant morbidities. LYR-210 and LYR-220 are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and are intended to deliver up to six months of continuous mometasone furoate drug therapy to the sinonasal passages as an alternative to sinus surgery. LYR-210 is designed for surgically naive patients and is being evaluated in the ENLIGHTEN Phase 3 clinical program, while LYR-220, an enlarged matrix, is being evaluated in patients who have recurrent symptoms despite surgery in the BEACON Phase 2 clinical trial. These two product candidates are designed to treat the estimated four million CRS patients in the United States who fail medical management each year.

Our Clinical Affairs team is growing, and we are currently seeking a Lead Clinical Research Associate to join our team.  The in-house Lead Clinical Research Associate (LCRA) will provide operational oversight and leadership to ensure the integrity of the trial data. The in-house LCRA will be accountable for site compliance for assigned protocols and will support the Clinical Team with study related tasks. In addition, they will provide oversight of monitoring activities for assigned studies, which includes review of monitoring visit reports and accurate documentation and implementation of corrective actions. The in-house LCRA will participate in inspection readiness activities and may co-monitor sites, along with the CRO, to ensure data integrity.  

Key Responsibilities Include:

• Oversee clinical trial site performance, adequacy of monitoring activities and documentation for assigned protocols
• Review monitoring visit reports and follow-up letters and escalate monitoring trends or findings (i.e. deviations, deficiencies, etc.) and recommend actions to secure compliance
• Review monitoring metrics on a regular basis and ensure compliance with SOPs and study plans
• Communicate with the CRO and the internal team, escalating issues that require corrective actions
• May perform remote, co-monitoring & monitoring oversight activities to assure study conduct adheres to ICH GCP, Standard Operating Procedures (SOPs), study protocol and applicable study plan(s)
• Provide internal support to clinical team to facilitate site identification/feasibility, site management, and study closeout
• Participate in clinical data review, including resolving queries, as part of the database cleaning process in conjunction with the Clinical Research Organization (CRO)
• Assist in the development of study plans/documents and tools
• Track and monitor the progress of assigned clinical trials, such as essential document tracking, patient status/enrollment tracking and trial supply tracking
• Respond to sites' IRB/IEC requests for protocol and ICF clarification, as needed
• Ensure inspection-ready files by conducting periodic Trial Master File (TMF) audits
• Contact study sites for specific requests (e.g. recruitment updates, missing documentation, action item resolution status) or issues related to study conduct and other sponsor-specific CRA tasks
• Flag potential issues for the Clinical Operations Study Lead and work with clinical team to resolve issues
• Support audit/inspection readiness activities, including but not limited to mock audits, support during on-site audits, storyboard generation, documentation of corrective action plans
• Interact with sites, vendors and internal study team members and participate in internal and external cross-functional team meetings
• Other duties may be assigned as deemed necessary by Clinical Operations Study Lead or Head of Clinical Operations

Requirements

• Bachelor's Degree or equivalent is required.
• 5+ years of related Clinical Research experience with at least 3 years of on-site monitoring experience
• Inspection readiness experience is required
• Proven oversight skills for a remote team, driving results and collaboration in a global environment
• Proficiency with Microsoft Office Suite, electronic data systems, and other database programs
• Exceptional organizational skills, attention to detail and accuracy; able to work independently and maintain confidentiality
• Excellent verbal and written communication skills and the ability to communicate effectively
• A working knowledge of FDA regulations, ICH/GCP and other regulatory requirements
• Ability to work in a fast-paced environment
• Willing and capable of business travel within North America for as much as 30% of time or as required by specific study/project needs

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.