Note: The job is a remote job and is open to candidates in USA. Alira Health is a global team dedicated to innovation and initiative, and they are seeking a Lead Clinical Research Associate. The Lead CRA will provide oversight and leadership in managing clinical trial monitoring, ensuring compliance and quality while collaborating with various stakeholders.
Responsibilities
- Provides guidance, oversight, and feedback to the field CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements
- Ensures quality of data is in line with clinical standards and that the rights and safety of patients involved in studies are protected
- Monitors performance of CRAs on a continuous basis, including reviewing monitoring visit reports and conducting co-monitoring visits as needed
- Performs CRA mentoring and oversight of CRA activities including evaluation of quality of work through co-monitoring
- Ensures appropriate and timely investigator site visits
- Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues
- Assists in development of study-specific Clinical Monitoring Plans and training presentations as needed
- Assists in resourcing CRAs for planned and ongoing clinical trials
- Supports CRA hiring through initial screening, phone, and video interviews of potential new employees
- Responsible for CRA new hire training and onboarding
- Conducts review of CRA time and expenses, as appropriate
- Provides monthly billing information to finance team
- Performs qualification, initiation, interim, and close-out visits both onsite and remote, ensuring proper documentation of monitoring visits
- Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status
- Ensures integrity of CRF data through meticulous and thorough source document review and verification
- Conducts investigational product accountability
- Reviews site regulatory binder for required documents, performing quality assurance of documents collected at sites for uploading to eTMF/TMF
- Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests
- Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs
- Proactively identifies site issues and develops problem-solving strategies
- Conducts audit preparation at study sites as needed
- Supports study team with set-up, collection of site specific ethics documents and site contract negotiation as required
- Participates and attends bid defense meetings as required
- Supports improvement and set up of new company processes/procedures related to monitoring activities
- Collaborates with development and maintenance of Clinical Trial Management System (CTMS)
- Promote a collaborative team atmosphere between CRAs
- Participates in internal, client/sponsor, scientific, and other meetings as required
- Performs additional duties as assigned
Skills
- BS/BA from an undergraduate program (life sciences or related discipline preferred)
- 4 years of experience in the pharmaceutical / biotechnology / CRO industry
- 2 years' experience in clinical monitoring with 1 year of management experience
- Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 (for EU applicants)
- Extensive experience in clinical monitoring, in local and international studies, multiple therapeutical areas and phases
- Excellent knowledge of clinical research, ICH GCP, regulatory, ethical and local regulations
- Proven ability to be careful, thorough, detail-oriented and quality focused
- Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment; able to manage priorities and organize time
- Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
- Ability to problem-solve unstructured or ambiguous challenges
- Strong command of English, both written and verbal
- Excellent communication and interpersonal skills with customer service orientation
- Good computer skills, with ability to use CTMS systems, clinical trial databases and electronic data capture
- Ability to travel
- Professional, trustworthy and disciplined
- Able to manage stress and conflicts
- Leadership attitude
- Problem solving skills
- Self-starter who thrives in a collaborative, yet less structured team environment
- Permanent authorization to work in the U.S. (for US applicants)
- Graduation in a scientific/health field
- Experience in clinical project management is not mandatory but is considered as a plus
- Knowledge of Pharmacovigilance processes
- Adequate English
Company Overview