Senior Clinical Research Associate

Alira Health

Job Overview

Location

Indiana, USA

Job Type

Full-time

Full Job Description

📋 Description

• As a Senior Clinical Research Associate (Sr CRA) at Alira Health, you will be an integral and highly motivated member of our global Clinical team, driving innovation and excellence in clinical trial execution.
• This role is pivotal in ensuring the successful monitoring of clinical trials, providing essential oversight, leadership, and guidance to maintain the highest standards of compliance and quality.
• You will operate with a significant degree of independence, managing site monitoring responsibilities and contributing to the overall success of clinical trial projects.
• Your collaboration will extend across various internal teams, including the US Director of Clinical Monitoring, Lead CRAs, in-house CRAs, and the EU Associate Director of Clinical Monitoring, CRAs, and Project Managers.
• You will be instrumental in addressing site-specific challenges, supporting study recruitment efforts, conducting comprehensive site training, and resolving a wide array of site-related issues.
• A key aspect of your role will involve providing expert guidance, oversight, and constructive feedback to the broader CRA team, ensuring strict adherence to project scope, Standard Operating Procedures (SOPs), established timelines, and budgetary constraints.
• You will meticulously review monitoring visit reports, conduct co-monitoring visits, and perform evaluation visits as necessary to uphold quality standards.
• Ensuring the appropriateness and timeliness of investigator site visits will be a critical responsibility, guaranteeing that sites are adequately supported and monitored throughout the trial lifecycle.
• You will act as a central point of coordination, liaising with various cross-functional departments to facilitate the negotiation of contracts and the swift resolution of any issues that arise in relation to clinical trial monitoring.
• You will actively contribute to the development of study-specific Monitoring Plans and the creation of essential training presentations, tailoring them to the unique needs of each trial.
• Assisting in the setup and collection of site-specific ethics documents and supporting site contract negotiations will be part of your remit, ensuring all necessary approvals and agreements are in place.
• For standalone monitoring projects, you will assume responsibility for managing the study budget and serving as the primary point of contact and reference for the sponsor, fostering strong client relationships.
• You will perform comprehensive qualification, initiation, interim, and close-out visits, utilizing both remote and onsite methodologies, and meticulously documenting all monitoring activities.
• Preparing consistently accurate and timely monitoring visit reports will be essential, detailing site-specific problems, the resolutions implemented, actions taken, protocol deviations, overall study progress, and enrollment status.
• Ensuring the integrity of Case Report Form (CRF) data through meticulous and thorough source document review and verification is paramount to data accuracy and reliability.
• You will conduct quality control checks and verification of documents collected at sites, ensuring their completeness and accuracy for inclusion in the electronic Trial Master File (eTMF) or Trial Master File (TMF).
• Performing investigational product accountability checks will be a routine part of your responsibilities, ensuring proper tracking and management of study medication.
• Reviewing site regulatory binders for required documents will be crucial for maintaining compliance and audit readiness.
• Maintaining regular, proactive contact with study sites is vital to ensure protocol and Good Clinical Practice (GCP) compliance, assess patient accrual rates, and respond promptly to sponsor requests.
• You will ensure strict compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs, and will foster a culture of compliance within the team.
• Participation in internal, client/sponsor, scientific, and other relevant meetings will be required, contributing your expertise and insights.
• You will facilitate adverse event reporting processes and ensure the accurate reconciliation of Serious Adverse Event (SAE) reports with source documentation and CRFs.
• Collaborating closely with in-house CRAs/CTCs and data management teams to resolve queries on discrepant data will be essential for maintaining data quality.
• Proactively identifying potential site issues and developing effective problem-solving strategies for sites will be a key differentiator in this role.
• You may be called upon to conduct audit preparation activities at study sites, ensuring readiness for regulatory inspections.
• Working collaboratively with other CRAs to maintain consistency across studies and promote a positive, supportive team atmosphere is highly valued.
• You will play a role in the training and onboarding of new CRA hires, sharing your knowledge and experience.
• Performing CRA mentoring will be an important aspect of developing talent within the team.
• You will collaborate in the development and maintenance of the Clinical Trial Management System (CTMS), contributing to system improvements.
• Effectively managing and resolving conflicting priorities will be necessary to consistently deliver on commitments and meet project deadlines.
• Performing additional duties as assigned will ensure flexibility and support for broader team objectives.
• This role offers the opportunity to work remotely across Europe, contributing to groundbreaking clinical research within a dynamic and values-driven global organization.

🎯 Requirements

• Minimum of 2 years of clinical monitoring experience in the pharmaceutical, biotechnology, or CRO industry (EU specific).
• Strong command of the local language in the country where monitoring activities are performed, along with adequate English proficiency (EU specific).
• Knowledge of clinical research, ICH GCP, and local regulations, including regulatory and ethical requirements.

🏖️ Benefits

• Opportunity to work remotely across Europe.
• Be part of a global team dedicated to innovation and collaboration.
• Contribute to impactful clinical trials in a values-driven organization.
• Professional development and mentoring opportunities.

Skills & Technologies

GCP

Senior

Remote

Degree Required

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Alira Health

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About Alira Health

Alira Health is a global healthcare consulting firm that provides advisory and analytics services to life sciences and healthcare organizations. They focus on helping clients navigate complex challenges in areas such as market access, commercial strategy, digital health, and patient outcomes. Their expertise spans the entire healthcare ecosystem, from pharmaceutical and medical device companies to providers and payers. Alira Health leverages data-driven insights and deep industry knowledge to develop tailored solutions that drive growth, improve patient care, and optimize healthcare delivery. They are committed to advancing healthcare innovation and improving the lives of patients worldwide.

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