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
ABOUT ALIRA HEALTH
At Alira Health, our mission is to enable healthcare transformation. Our team collaborates fully to understand every aspect of each client's organization from concept ideation to commercial realization; from innovation to implementation. We support our clients with a full spectrum of patient-centric data and tech-enabled services.
Our clients are global, and so are we. Our local presence and global collaboration allow us to deliver actionable business insights and an unmatched continuum of support across the full corporate and product lifecycle. We operate across thirteen offices located in Boston and San Francisco in the US; Barcelona, Basel, Bologna, Geneva, Milan, Munich, Paris and Verona in Europe; Cambridge, United Kingdom; Sydney, Australia; and Toronto, Canada.
Job Description
THE IN-HOUSE CLINICAL RESEARCH ASSOCIATE (CRA) ROLE
- The In-house CRA is an important member of the Alira Health Clinical team. In-house CRAs manage and support clinical sites from site approval through close-out. In-house CRAs work closely with field CRAs and Clinical Project Managers to ensure the integrity of the trial data without the need for frequent travel.
ESSENTIAL JOB FUNCTIONS
Develops study documents and tools, including Informed Consent Form (ICF) templates (for both local and central IRBs), site binder contents, etc.Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFsResponds to sites' regulatory board requests for protocol and ICF clarification as neededEnsures all required site regulatory documents and approvals are in place prior to investigational product shipmentEnsures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviewsAnalyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sitesMaintains regular communication with study sites to ensure protocol / GCP compliance, assesses subject accrual rates, and responds to sponsor requestsConducts remote review of data entered on electronic Case Report Forms (eCRFs)Works closely with field CRAs and data management to resolve queries on discrepant dataAssists with efforts to recruit investigative sites to participate in clinical studiesComplies with ICH GCP guidelines, FDA regulations, and company SOPsParticipates in internal, client / sponsor, scientific, and other meetings as requiredManages and resolves conflicting priorities to deliver on commitmentsPerforms additional duties as assigned
PREPARATION, KNOWLEDGE, SKILLS & ABILITIES
BS / BA from an undergraduate program or equivalent experience1-2 years of experience in clinical researchProven ability to be careful, thorough, and detail-orientedStrong organizational skills and the ability to multi-task and work effectively in a fast-paced environmentStrong analytical, negotiation, meeting management, cross-functional team, and leadership skillsSelf-starter who thrives in a collaborative, yet less structured team environmentAbility to problem-solve unstructured or ambiguous challengesStrong command of English, both written and verbalExcellent communication and interpersonal skills with customer service orientationProficient with MS Office Suite, particularly Word and ExcelPermanent authorization to work in the U.S.WORKING CONDITIONS / PHYSICAL DEMANDS
Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting up to 30 lbs.Languages
English
Education
Bachelor of Arts (BA), Bachelor of Science (BS)
Contract Type
Regular
