Sr. In-house Clinical Research Associate

Alira Health Boston, LLC; Framingham (MA); On-site; USD 75,000 - 90,000; Full time

Benefits offered by this job

Professional development

Global travel

Flexible work programs

Job summary

Alira Health Boston, LLC is seeking a Sr. In-house Clinical Research Associate (CRA) to manage and support clinical sites from site approval through close-out, collaborating with field CRAs and Clinical Project Managers to uphold trial data integrity with minimal travel.

The role requires a BS/BA, 7+ years in clinical research, strong organization, communication, and leadership, and permanent U.S. work authorization.

Qualifications

• BS/BA or equivalent experience.
• 7+ years of clinical research experience.
• Strong written and spoken English with attention to detail.

Responsibilities

• Develops study documents and tools, including ICF templates (local and central IRBs) and ISF contents.
• Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs.
• Ensures regulatory documents are collected and filed at site and in the TMF; conducts routine file reviews.
• Analyzes site performance issues and provides ongoing training for study sites.
• Maintains regular communication with study sites to ensure protocol/GCP compliance and patient accrual.
• Assists with site recruitment and data query resolution with field CRAs and data management.

Skills

Organizational skills

Analytical skills

Leadership

Communication skills

Problem-solving

Project management

Education

Bachelor of Science (BS)

Tools

MS Office (Word, Excel)

Job description

Job Description Summary Job Description THE IN-HOUSE CLINICAL RESEARCH ASSOCIATE (CRA) ROLE The Sr. In-house CRA is an important member of the Alira Health Clinical team. The Sr. In-house CRAs manage and support clinical sites from site approval through close-out. Sr. 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), Investigator Site File (ISF) contents, etc.
• Supports sites in obtaining IRB approval, developing submission materials, and creating sitespecific 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) as needed
• 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
• At least 7 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 of weight up to 30 lbs.

Languages

English

Education

Bachelor of Science (BS)

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. 75,000 - 90,000

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. Learn more