Clinical Research Associate
Jobbeschreibung
Basel, Basel-Stadt, Schweiz
Alira Health
27.04.2024
Möchten Sie Updates für diesen und ähnliche Jobs?
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 SummaryJob DescriptionROLEThe 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 RESPONSABILITIESPerforms 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 & EXPERIENCEBS/BA from an
undergraduate program or equivalent experience2 years of clinical
research experienceTECHNICAL COMPETENCES & SOFT SKILLSAbility 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 environmentAbility 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.LanguagesEnglishEducationSummaryLocation: Framingham; London;
Padova; Paris; San Francisco; Basel; Barcelona; Verona; Milan;
Bologna; Munich; Bordeaux; Toronto; Sydney; GenevaType: Full time