Clinical Research Associate

Alira Health is seeking a Clinical Research Associate to independently conduct and oversee clinical trial site monitoring activities while ensuring protocol compliance, quality, and regulatory adherence. The role manages site visits, monitoring documentation, data verification, investigator relationships, issue resolution, and CRA team support.

Responsibilities

Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements

Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed

Ensures appropriate and timely investigator site visits

Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues

Assists in development of study-specific Monitoring Plans and training presentations as required

Assists in set up/collection of site specific ethics documents and site contract negotiation as required

Provides monthly billing information to finance team as required

For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor

Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits

Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status

Ensures integrity of CRF data through meticulous and thorough source document review and verification

Performs quality control and verification of documents collected at sites for eTMF/TMF

Conducts investigational product accountability

Reviews site regulatory binder for required documents

Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests

Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs

Participates in internal, client/sponsor, scientific, and other meetings as required

Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs

Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data

Proactively identifies site issues and develops problem-solving strategies for sites

Conducts audit preparation at study sites as needed

Works with other CRAs to maintain consistency and promote a collaborative team atmosphere

Participates in internal, client/sponsor, scientific, and other meetings as required

Assists in CRA new hire training and onboarding

Performs CRA mentoring

Collaborates with development and maintenance of Clinical Trial Management System (CTMS)

Manages and resolves conflicting priorities to deliver on commitments

Performs additional duties as assigned

2+ years monitoring experience

Preferred

Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members

Ability to autonomously manage monitoring activities

Quality focused; 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

Able to manage priorities, organize time and solve problems

Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills

Professional, trustworthy and disciplined

Ability to problem-solve unstructured or ambiguous challenges

Excellent communication and interpersonal skills with customer service orientation

Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture

Self-starter who thrives in a collaborative, yet less structured team environment

Knowledge of clinical research, ICH GCP and local regulations

Knowledge of Regulatory and Ethical requirements

Monitoring Activities

Clinical Trial Management Systems

Clinical Trial Databases

Electronic Data Capture

Clinical Research

ICH GCP

Local Regulations

Regulatory Requirements

Ethical Requirements

Relationship Building

Autonomous Work

Quality Focus

Attention to Detail

Thoroughness

Organization

Multitasking

Priority Management

Time Management

Problem-Solving

Analytical Thinking

Negotiation

Meeting Management

Cross-Functional Teamwork

Leadership

Professionalism

Trustworthiness

Self-Discipline

Communication

Interpersonal Skills

Customer Service Orientation

Initiative

Collaboration

Adaptability

Benefits

Remote work arrangement

Company

Patient-centric healthcare consultancy and CRO for life sciences

Paris, Ile-de-France, FRA

https://www.alirahealth.com/

Founded in 1999

501-1000 employees

Qualifications

2+ years monitoring experience

Strong command of Local language, both written and verbal, in the country where monitoring activities are performed

English

Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences

Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members

Ability to autonomously manage monitoring activities

Quality focused; 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

Able to manage priorities, organize time and solve problems

Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills

Professional, trustworthy and disciplined

Ability to problem-solve unstructured or ambiguous challenges

Excellent communication and interpersonal skills with customer service orientation

Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture

Self-starter who thrives in a collaborative, yet less structured team environment

Knowledge of clinical research, ICH GCP and local regulations

Knowledge of Regulatory and Ethical requirements

2+ years monitoring experience.

Required skills

Clinical Trial Monitoring, Clinical Research, ICH GCP, Clinical Trial Management Systems (CTMS), Clinical Trial Databases, Electronic Data Capture (EDC), Regulatory and Ethical Requirements

Preferred skills

Ability to autonomously manage monitoring activities, Able to manage priorities, organize time and solve problems, Professional, trustworthy and disciplined, Knowledge of Regulatory and Ethical requirements

Experience

2+ years