Apply on Employer Site

Alira Health · 6 days ago

Sr. In-house Clinical Research Associate

Greater Boston

Full-time

Onsite

Senior Level

$75K/yr - $95K/yr

7+ years exp

Alira Health is a global team dedicated to innovation and initiative, and they are seeking a Sr. In-house Clinical Research Associate. This role involves managing and supporting clinical sites from approval through close-out, ensuring the integrity of trial data while minimizing travel.

BiotechnologyConsultingHealth Care

No H1B

Responsibilities

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

Qualification

Clinical research experienceRegulatory document managementGCP complianceMS Office SuiteAnalytical skillsCommunication skillsOrganizational skillsProblem-solving skillsLeadership skills