What are the responsibilities and job description for the Clinical Research Associate position at Alira Health?
Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values : be courageous, be accountable, be honest, be inclusive and elevate others.
Job Description Summary
Job Description
ROLE
The Clinical Research Associate is an important member of the Alira Health Clinical team. CRAs are highly motivated and function independently to conduct site monitoring responsibilities for clinical trials. CRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites' protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.
KEY RESPONSABILITIES
- Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits.
- Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
- Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.
- Ensures integrity of CRF data through meticulous and thorough source document review and verification.
- Conducts investigational product accountability.
- Reviews regulatory binder for required documents.
- Works closely with in-house CRAs and data management to resolve queries on discrepant data.
- Proactively identifies site issues and develops problem-solving strategies for sites.
- Maintains regular contact with study sites to ensure protocol / GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
- Conducts audit preparation at study sites as needed.
- Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
- Manages and resolves conflicting priorities to deliver on commitments.
- Complies with ICH GCP guidelines, FDA regulations, and company SOPs.
- Participates in industry and client meetings.
- Performs additional duties as assigned.
DESIRED QUALIFICATION & EXPERIENCE
TECHNICAL COMPETENCES & SOFT SKILLS
Languages
English
Education
Bachelor of Science (BS) : Biology, Bachelor of Science (BS) : Life Sciences
Contract Type
Regular
