Senior Clinical Research Associate (Sr CRA)

Employment Type: Part-time

Position Overview

Alira Health is seeking a motivated and independent Senior Clinical Research Associate (Sr CRA) to join our global Clinical team. This role is crucial for ensuring the quality and compliance of clinical trials. The Sr CRA will provide oversight, leadership, and guidance in the management and execution of clinical trials, working collaboratively with internal teams and study sites.

Key Responsibilities

• Team Guidance & Oversight:
  • Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
  • Conduct co-monitoring and evaluation visits as needed.
  • Assist in CRA new hire training and onboarding.
  • Perform CRA mentoring.
• Site Monitoring & Management:
  • Perform qualification, initiation, interim, and close-out visits both remotely and onsite.
  • Ensure appropriate and timely investigator site visits.
  • Prepare consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
  • Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual rates, and respond to sponsor requests.
  • Proactively identify site issues and develop problem-solving strategies for sites.
  • Conduct audit preparation at study sites as needed.
• Data Integrity & Compliance:
  • Ensure integrity of CRF data through meticulous and thorough source document review and verification.
  • Perform quality control and verification of documents collected at sites for eTMF/TMF.
  • Conduct investigational product accountability.
  • Review site regulatory binder for required documents.
  • Facilitate adverse event reporting and ensure the reconciliation of SAE reports with source documentation and CRFs.
  • Comply with and ensure team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.
• Study Support & Coordination:
  • Assists in development of study-specific Monitoring Plans and training presentations as required.
  • Assists in set up/collection of site specific ethics documents and site contract negotiation as required.
  • Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data.
  • Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.
• Administrative & Financial:
  • Provides monthly billing information to finance team as required.
  • For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.
• Collaboration & Meetings:
  • Works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers.
  • Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
  • Collaborates with development and maintenance of Clinical Trial Management System (CTMS).
  • Participates in internal, client/sponsor, scientific, and other meetings as required.
• Other Duties:
  • Performs additional duties as assigned.
  • Manages and resolves conflicting priorities to deliver on commitments.

Desired Qualifications & Experience

• US: BS/BA from an undergraduate program (life sciences or related discipline preferred).
• US: 3 years of experience in the pharmaceutical / biotechnology / CRO industry.
• US: 2 years of clinical monitoring experience.

Company Culture

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. We foster an environment where all contributions and new ideas are explored with an open mind, driven by our shared values: be courageous, be accountable, be honest, be inclusive, and elevate others.

Application Instructions

• If you are being referred to one of our roles by a connection in Alira Health, please apply using the referral link emailed to you.