In-House Clinical Research Associate

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

Benefits

Remote work

Patient-centric healthcare consultancy and CRO for life sciences.

Paris, Ile-de-France, FRA

https://www.alirahealth.com

Late Stage

Total Funding

$233M

Key Investors

Symbiotic Capital

Creadev

2024-12-17

Debt Financing· $100M

2023-01-09

Series Unknown· $58M

2022-01-13

Series Unknown· $40M

Leadership Team

Gabriele Brambilla

CEO

Annabel de Maria

Chief Patient Officer

Recent News

GlobeNewswire

Alira Health Joins PFMD Effort to Advance Patient-Centered Evidence Generation

2026-04-30

BioSpace

Alira Health and Autoimmune Neurology Alliance (AiNA) Launch AXIS Registry, Advancing Real-World and Patient-Centered Research in Autoimmune Neurology

2026-04-16

Global Medtech CDMO Market Grows to $96.5B in 2025 as Pharma-Medtech Convergence Emerges as a Defining Accelerator

2026-03-31

Qualifications

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

Required skills

Clinical research, ICH Good Clinical Practice (GCP), FDA regulations, Microsoft Word, Microsoft Excel

Experience

1-2 years