Clinical Research Associate; Oncology Monitoring Experience Required

Alira Health Group; Treviso; Remoto; USD 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A global healthcare advisory firm is seeking a Clinical Research Associate with at least 2 years of oncology monitoring experience. The role involves conducting site monitoring for clinical trials to ensure compliance and quality. Candidates should possess a Bachelor of Science in a relevant field and demonstrate strong organizational abilities. This remote position offers a collaborative work environment with opportunities for professional growth.

Servizi

Professional development

Global travel

Flexible work programs

Competenze

• 2+ years oncology monitoring experience required.
• Degree in a scientific health field necessary.
• Ability to manage monitoring activities autonomously.

Mansioni

• Conduct site monitoring for clinical trials.
• Ensure protocol compliance and quality.
• Prepare accurate and timely monitoring visit reports.

Conoscenze

Oncology monitoring experience

Detail-oriented

Analytical skills

Communication skills

Organizational skills

Formazione

Bachelor of Science (Biology or Life Sciences)

Certified Monitor (EU, Italy compliance)

Strumenti

Clinical Trial Management System (CTMS)

Electronic Data Capture

Descrizione del lavoro

Clinical Research Associate; Oncology Monitoring Experience Required page is loaded

Clinical Research Associate; Oncology Monitoring Experience Required Apply remote type Remote locations Boston-Remote Americas-Remote time type Full time posted on Posted 2 Days Ago job requisition id JR000420

Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you.

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values : be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary

The CRA is an important member of the Alira Health Clinical team. The 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 CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.

Job Description

2+ years oncology monitoring is a requirement for this position. KEY RESPONSABILITIES

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.

DESIRED QUALIFICATION & EXPERIENCE

EU : Graduation in a scientific health field

EU (Italy) : Certified Monitor in compliance with Italian CRO decree dated 15Nov2011

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

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

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

EU : Adequate English

Languages

English

Education

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

Contract Type

Regular About Us

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 MedTech clients with a full spectrum of services across their entire solutions lifecycle.

Why Work at Alira Health?

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.

Join Our Team

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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