Note: The job is a remote job and is open to candidates in USA. Alira Health is a global team dedicated to innovation and collaboration. The Clinical Research Associate (CRA) plays a crucial role in conducting site monitoring for clinical trials, ensuring compliance, and providing guidance to the CRA team.
Responsibilities
- Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements
- Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed
- 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 Monitoring Plans and training presentations as required
- Assists in set up/collection of site specific ethics documents and site contract negotiation as required
- Provides monthly billing information to finance team as required
- For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor
- Performs qualification, initiation, interim, and close-out visits both remotely and onsite, 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
- Performs quality control and verification of documents collected at sites for eTMF/TMF
- Conducts investigational product accountability
- Reviews site regulatory binder for required documents
- 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
- Participates in internal, client/sponsor, scientific, and other meetings as required
- Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs
- Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data
- Proactively identifies site issues and develops problem-solving strategies for sites
- Conducts audit preparation at study sites as needed
- Works with other CRAs to maintain consistency and promote a collaborative team atmosphere
- Participates in internal, client/sponsor, scientific, and other meetings as required
- Assists in CRA new hire training and onboarding
- Performs CRA mentoring
- Collaborates with development and maintenance of Clinical Trial Management System (CTMS)
- Manages and resolves conflicting priorities to deliver on commitments
- Performs additional duties as assigned
Skills
- Quality focused; Proven ability to be careful, thorough, and detail-oriented
- Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
- Able to manage priorities, organize time and solve problems
- Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
- Ability to travel
- Ability to manage stress
- Professional, trustworthy and disciplined
- Ability to problem-solve unstructured or ambiguous challenges
- Excellent communication and interpersonal skills with customer service orientation
- Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture
- Self-starter who thrives in a collaborative, yet less structured team environment
- Knowledge of clinical research, ICH GCP and local regulations
- Knowledge of Regulatory and Ethical requirements
- Bachelor of Science (BS): Biology
- Bachelor of Science (BS): Life Sciences
- Graduation in a scientific health field
- Certified Monitor in compliance with Italian CRO decree dated 15Nov2011
- Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
- Ability to autonomously manage monitoring activities
- Strong command of Local language, both written and verbal, in the country where monitoring activities are performed
- Adequate English
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