Senior Clinical Research Associate

Job Description

The Sr CRA is an important member of the Alira Health Clinical team.

The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials to ensure compliance and quality.

The Sr 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.

Key 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 e TMF/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.
• Conducts audit preparation at study sites as needed.
• Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
• 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.
• Desired Qualifications & Experience
• US: BS/BA from an undergraduate program (life sciences or related discipline preferred)
• US: 3 years of experience in the pharmaceutical / biotechnology / CRO industry, 2 year 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
• Technical Competences & Soft Skills
• 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
• Ability to travel
• Ability to manage stress
• Professional, trustworthy and disciplined
• Ability to problem-solve unstructured or ambiguous challenges
• US: Strong command of English, both written and verbal
• EU: Strong command of Local language, both written and verbal, in the country where monitoring activities are performed
• 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
• Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
• US: Permanent authorization to work in the U. S.
• EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011.
• EU: Graduation in a scientific health field.
• EU: Adequate English Languages
• English Education Bachelor of Science (BS): Biology
• English Education Bachelor of Science (BS): Biotechnology
• English Education Bachelor of Science (BS): Life Sciences
• English Education Bachelor of Science (BS): Pharmacy
• Contract Type
• Contingency Workforce
• Salary Range

Salary Range The final offer will be determined within the applicable location-specific range and will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope.

Company Culture

Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance.

From development to medical care, we complement the expertise of our Pharma, Biotech, and Med Tech clients with a full spectrum of services across their entire solutions lifecycle.

With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more.

We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork.

We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities.

This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.

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