In-House Clinical Research Associate page is loaded

In-House Clinical Research Associate Apply locations Boston-Remote time type Full time posted on Posted 30+ Days Ago job requisition id JR000039

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 ICFs

• Responds to sites’ regulatory board requests for protocol and ICF clarification as needed

• Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment

• Ensures all regulatory documents are collected and filed appropriately at both the site and in the Trial Master File (TMF); conducts routine file reviews

• Analyzes site performance problems (protocol adherence) and identifies solutions; provides ongoing training for study sites

• Maintains regular communication with study sites to ensure protocol/GCP compliance, assesses subject accrual rates, and responds to sponsor requests

• Conducts remote review of data entered on electronic Case Report Forms (eCRFs)

• Works closely with field CRAs and data management to resolve queries on discrepant data

• Assists with efforts to recruit investigative sites to participate in clinical studies

• Complies with ICH GCP guidelines, FDA regulations, and company SOPs

• Participates in internal, client/sponsor, scientific, and other meetings as required

• Manages and resolves conflicting priorities to deliver on commitments

Performs additional duties as assigned

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

• BS/BA from an undergraduate program or equivalent experience

• 1-2 years of experience in clinical research

• 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

• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills

• 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 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

Education

Similar Jobs (1) Clinical Research Associate locations Boston-Remote time type Full time posted on Posted 30+ Days Ago

Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle.

Why Work at Alira Health?

With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork.

Join Our Team

We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.

Introduce yourself to our Recruiters! Apply to one of our open jobs or send us your spontaneous application.

#J-18808-Ljbffr