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
* BS/BA from an undergraduate program or equivalent experience
* 2 years of clinical research experience
TECHNICAL COMPETENCES & SOFT SKILLS
* Ability to travel.
* 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.
* Self-starter who thrives in a collaborative, yet less structured team environment
* 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.
* Proficient with MS Office Suite, particularly Word and Excel.
* Permanent authorization to work in the country where you are applying.
Languages
English
Education
Why us? SAS Retail Services is part of the largest retail services company in the US, working with major consumer brands in Walmart stores in your area. We display it, we move it, and we track it! Start building your career working with amazing people. Our on-the-job...
...Position Summary: The Onboarding Specialist will play a crucial role in ensuring a smooth and positive transition for new hires. This individual... ...and interpersonal skills. Proficiency in using HR software and systems. Attention to detail and accuracy....
...growth with competitive salaries and benefits in an exciting, entrepreneurial industry. Job Description/Responsibilities: The Safety Coordinator leads the safety culture for 1820 Spirits; leads the development and execution of a sound safety program to achieve zero...
...Agent. The ideal candidate will be able to provide excellent customer service and will require the ability to work independently. No experience... ..., we will provide training and credentials. This is a 100% remote job. Essential Functions: Provide exceptional customer...
...automation, youll also be helping off-platform software engineers migrate performance-sensitive... ...Previous experience as a senior developer, team lead or above Experience with... ...compensation, benefits, training, and apprenticeship. Reach Financial makes hiring decisions...