Senior Clinical Research Associate

Job Summary

Alira Health is searching for a permanent Senior CRA in the Netherlands or Belgium.

The Senior CRA is an important member of the Alira Health Clinical team. The Senior CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The Senior CRA works closely with US:
Director of Clinical Monitoring, Lead CRAs, in‑house CRAs, EU:
Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site‑related issues.

• Provide guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
• Review monitoring visit reports; conduct co‑monitoring and evaluation visits as needed.
• Ensure appropriate and timely investigator site visits.
• Coordinate with cross‑functional departments to facilitate negotiation or issue resolution for clinical trial monitoring related issues.
• Assist in the development of study‑specific monitoring plans and training presentations.
• Assist in setting up and collecting site‑specific ethics documents and site contract negotiation.
• Provide monthly billing information to the finance team.
• For monitoring stand‑alone projects, manage the study budget and act as the referent for the sponsor.
• Perform qualification, initiation, interim, and close‑out visits both remotely and onsite, ensuring proper documentation of monitoring visits.
• Prepare consistently accurate and timely monitoring visit reports documenting site‑related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
• Ensure integrity of CRF data through meticulous source document review and verification.
• Perform quality control and verification of documents collected at sites for eTMF/TMF.
• Conduct investigational product accountability and review site regulatory binder for required documents.
• Maintain regular contact with study sites to ensure protocol/GCP compliance, assess patient accrual rates, and respond to sponsor requests.
• Comply with and ensure team compliance with ICH GCP guidelines, FDA regulations, and company/sponsor SOPs.
• Participate in internal, client/sponsor, scientific, and other meetings as required.
• Facilitate adverse event reporting and ensure reconciliation of SAE reports with source documentation and CRFs.
• Work closely with in‑house CRAs/CTC and data management to resolve queries on discrepant data.
• Proactively identify site issues and develop problem‑solving strategies.
• Conduct audit preparation at study sites as needed.
• Work with other CRAs to maintain consistency and promote a collaborative team atmosphere.
• Assist in CRA new hire training and onboarding and perform CRA mentoring.
• Collaborate with development and maintenance of the Clinical Trial Management System (CTMS).
• Manage and resolve conflicting priorities to deliver on commitments and perform additional duties as assigned.

US:
Bachelor of Science or Bachelor of Arts from an undergraduate program (life sciences or related discipline preferred).

US: 3 years of experience in the pharmaceutical/biotechnology/CRO industry, 2 years of clinical monitoring experience with 1 year of management experience.

EU:
Minimum 2 years of clinical monitoring experience in the pharmaceutical/biotechnology/CRO industry and ability to autonomously manage monitoring activities.

US:
Permanent authorization to work in the U.S.; EU (Italy):
Certified Monitor in compliance with Italian CRO decree dated 15 November 2011; EU:
Graduation in a scientific health field; EU:
Local language proficiency in the country where monitoring activities are performed.

• Quality focused; detailed and thorough.
• Strong organizational skills and ability to multi‑task and work effectively in a fast‑paced environment.
• Excellent analytical, negotiation, meeting management, cross‑functional team, and leadership skills.
• Ability to travel.
• Ability to manage stress.
• Professional, trustworthy, and disciplined.
• Ability to problem‑solve unstructured or ambiguous challenges.
• Strong command of English (US); local language proficiency (EU).
• 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 thriving in a collaborative, yet less structured team environment.
• Knowledge of clinical research, ICH GCP and local regulations; knowledge of regulatory and ethical requirements.
• Ability to establish and maintain positive relationships with Sponsor, Site, and Project Team members.

Contract Type:
Regular.