Senior In-house Clinical Research Associate
Alira Health
full-time
Posted on:
Location Type: Hybrid
Location: Boston • Massachusetts • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
Google Cloud Platform
About the role
- 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 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) 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
Requirements
- 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.
Benefits
- Professional development
- Global travel
- Flexible work programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical researchprotocol adherenceregulatory document managementdata analysiseCRF reviewIRB approval processGCP complianceSOP compliancesite recruitmentfile review
Soft skills
detail-orientedorganizational skillsmulti-taskinganalytical skillsnegotiation skillsmeeting managementleadership skillsproblem-solvingcommunication skillsinterpersonal skills