Clinical Research Associate; Oncology Monitoring Experience Required

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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, inhouse 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 siterelated 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 comonitoring and evaluation visits as needed.

• Ensures appropriate and timely investigator site visits.

• Coordinates with appropriate crossfunctional departments to facilitate negotiationissue resolution for clinical trial monitoring related issues.

• Assists in development of studyspecific Monitoring Plans and training presentations as required.

• Assists in set upcollection of site specific ethics documents and site contract negotiation as required.

• Provides monthly billing information to finance team as required.

• For monitoring standalone projects, manages study budget and acts as referent for the sponsor.

• Performs qualification, initiation, interim, and closeout visits both remotely and onsite, ensuring proper documentation of monitoring visits.

• Prepares consistently accurate and timely monitoring visit reports documenting siterelated 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 eTMFTMF.

• Conducts investigational product accountability.

• Reviews site regulatory binder for required documents.

• Maintains regular contact with study sites to ensure protocolGCP compliance, assesses patient accrual rates, and responds to sponsor requests.

• Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and companySponsor SOPs.

• Participates in internal, clientsponsor, 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 inhouse CRAsCTC and data management to resolve queries on discrepant data.

• Proactively identifies site issues and develops problemsolving 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, clientsponsor, 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 detailoriented

    • Strong organizational skills and the ability to multitask and work effectively in a fastpaced environment

    • Able to manage priorities, organize time and solve problems

    • Strong analytical, negotiation, meeting management, crossfunctional team, and leadership skills

    • Ability to travel

    • Ability to manage stress

    • Professional, trustworthy and disciplined

    • Ability to problemsolve 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

    • Selfstarter 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