In-House Clinical Research Associate

Alira Health; Boston, Northern (MA, KY); Hybrid; USD 50,000 - 70,000; Full time

Job summary

Alira Health in the United States is seeking an In-house CRA to join our Clinical team. The role manages and supports clinical sites from site approval through close-out, with limited travel and close collaboration with field CRAs and Clinical Project Managers.

You will ensure data integrity, help prepare ICFs and regulatory submissions, review eCRFs remotely, and assist with site performance and training to support trials.

Qualifications

• BS/BA from an undergraduate program or equivalent experience.
• 1-2 years of experience in clinical research.
• Permanent authorization to work in the U.S.
• Languages English

Responsibilities

• Develops study documents and tools, including ICF templates for local and central IRBs.
• Supports sites in obtaining IRB approval and preparing submission materials.
• Responds to sites’ regulatory board requests for protocol and ICF clarifications.
• Ensures all regulatory documents are in place prior to investigational product shipment.
• Ensures regulatory documents are filed in TMF and conducts routine file reviews.
• Analyzes site performance issues and provides training for study sites.
• Maintains regular communication with study sites to ensure protocol compliance.
• Conducts remote review of data entered on eCRFs.
• Resolves queries on discrepant data with field CRAs and data management.

Skills

Attention to detail

Organizational skills

Multi-tasking

Analytical thinking

Cross-functional collaboration

Leadership

Problem-solving

Communication skills

English proficiency

Education

BS/BA

Tools

MS Word

MS Excel

Job description

Are you being referred to one of our roles by a connection in Alira Health?

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

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.

KEY RESPONSIBILITIES

• 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

DESIRED QUALIFICATION & EXPERIENCE

• BS/BA from an undergraduate program or equivalent experience
• 1-2 years of experience in clinical research
• Permanent authorization to work in the U.S.
• Languages English

TECHNICAL COMPETENCES & SOFT SKILLS

• 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

Contract Type

Regular

Salary Range

The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope. USD $50,000 - 70,000

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.

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.

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.