Clinical Research Associate- Wound Care Experience Required

Alira Health$95K – $120K per yearUnited States only

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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

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Clinical Research Associate- Wound Care Experience Required at Alira Health · ApplyPick

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.
2+ years experience in wound care monitoring is required.
DESIRED QUALIFICATION & EXPERIENCE
Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
Ability to autonomously manage monitoring activities
TECHNICAL COMPETENCES & SOFT 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
Strong command of Local language, both written and verbal, in the country where monitoring activities are performed
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
Languages

Clinical Research Associate- Wound Care Experience Required

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Job Description Summary

Clinical Research Associate- Wound Care Experience Required

Apply now

Job Description Summary

English Education

Salary Range

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