Clinical Research Associate
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Clinical Research Associate monitoring clinical trials for Alira Health’s global healthcare research team. Ensuring protocol compliance, site quality, regulatory documentation, and accurate clinical data.
Responsibilities:
- Conduct site monitoring responsibilities for clinical trials
- Provide oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality
- Provide guidance, oversight, and feedback to the CRA team regarding project scope, SOPs, timelines, and budgets
- Review monitoring visit reports and conduct co-monitoring and evaluation visits as needed
- Ensure appropriate and timely investigator site visits
- Coordinate cross-functional departments to resolve clinical trial monitoring issues
- Assist with study-specific Monitoring Plans and training presentations
- Assist with ethics document collection and site contract negotiation
- Provide monthly billing information to finance
- Manage study budgets and act as sponsor referent for stand-alone projects
- Perform qualification, initiation, interim, and close-out visits remotely and onsite
- Prepare accurate and timely monitoring visit reports
- Review and verify source documents and CRF data
- Perform quality control and verification of eTMF/TMF documents
- Conduct investigational product accountability
- Review site regulatory binders
- Maintain contact with study sites regarding protocol/GCP compliance, patient accrual, and sponsor requests
- Ensure compliance with ICH GCP, FDA regulations, and company/sponsor SOPs
- Participate in internal, client/sponsor, scientific, and other meetings
- Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs
- Collaborate with in-house CRAs/CTC and data management to resolve discrepant data queries
- Identify site issues and develop problem-solving strategies
- Conduct audit preparation at study sites as needed
- Collaborate with other CRAs to maintain consistency and teamwork
- Assist with CRA new hire training and onboarding
- Mentor CRAs
- Collaborate on Clinical Trial Management System (CTMS) development and maintenance
- Manage conflicting priorities and deliver commitments
- Perform additional assigned duties
Requirements:
- 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
- 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
- Bachelor of Science (BS) in Biology or Life Sciences
Benefits:
- Remote work arrangement
- Part-time employment
- Contingency Workforce contract type
Similar Jobs
Clinical Research Associate
Clinical Research Associate monitoring clinical trials for Alira Health’s global research team. Ensuring protocol compliance, site quality, data integrity, and regulatory adherence.
Clinical Research Associate
Clinical Research Associate monitoring clinical trials for global healthcare company Alira Health. Ensuring site compliance, data integrity, regulatory adherence, and study quality through remote and onsite visits.
Senior Clinical Research Associate
Senior Clinical Research Associate monitoring sponsor-dedicated clinical trials for ICON. Ensuring protocol compliance, site performance, data integrity, and regulatory standards.
Clinical Research Associate
Field-based Clinical Research Associate advancing AbbVie’s innovative medicines through clinical trials. Monitoring sites, ensuring compliance, and supporting patient recruitment and data integrity.
Senior Clinical Trial Manager
Clinical Trial Manager advancing Jade Biosciences’ autoimmune disease therapies through Phase 1–3 trials. Coordinating CROs, budgets, vendors, sites, compliance, and study execution.
Local Clinical Study Manager – Eastern Europe
Clinical Study Manager overseeing oncology and onco-hematology trials for IQVIA across Eastern Europe. Leading clinical teams, site activation, monitoring, regulatory delivery, and study execution.
Senior Clinical Research Associate – CRO-Contract
Contract Senior Clinical Research Associate monitoring clinical trial sites for Lotus Clinical Research. Ensuring GCP compliance, site documentation, investigational product accountability, and study close-out.
Senior Clinical Research Associate – CRO Contract
Contract Senior Clinical Research Associate monitoring clinical-trial sites for Lotus Clinical Research. Ensuring GCP, FDA, ICH, protocol, and study-document compliance through site visits.
Associate Clinical Data Manager – FSP
Associate Clinical Data Manager supporting sponsor-dedicated clinical trials at Fortrea. Managing clinical data queries, study timelines, validation processes, and data management standards.
Senior Clinical Research Associate
Senior Clinical Research Associate monitoring sponsor-dedicated Phase I oncology trials at ICON. Managing sites, ensuring GCP compliance, and guiding clinical trial teams.
Senior Clinical Research Associate
Senior Clinical Research Associate overseeing remote Phase I oncology trial monitoring for ICON Strategic Solutions. Managing sites, compliance, data integrity, and CRA guidance.
Senior Clinical Research Associate
Senior Clinical Research Associate monitoring respiratory and cardiovascular clinical trials for ICON in the Greater Toronto Area. Overseeing sites, compliance, data integrity, and trial execution.
Clinical Research Associate
Clinical Research Associate monitoring oncology and dermatology clinical trials for global CRO TFS HealthScience. Ensuring participant safety, data integrity, regulatory compliance, and accurate study-site documentation.
Clinical Trial Manager
Clinical Trial Manager managing timelines, quality, vendors, and stakeholders for ICON’s sponsor-dedicated clinical research programs. Supporting trials that advance patient treatments.
Clinical Research Associate II
Clinical Research Associate II monitoring Phase 1–4 clinical trials for AbbVie, a medicines and healthcare solutions company. Ensuring site compliance, data quality, safety reporting, and regulatory readiness.
Clinical Monitor, Clinical Research Associate, CRA
Clinical Research Associate monitoring German clinical trials for ClinSol’s contract research programs. Coordinating sites, regulatory submissions, study data, and investigator communication.
Clinical Research Associate
Clinical Research Associate monitoring sponsor-dedicated clinical trials for ICON Strategic Solutions. Ensuring protocol compliance, data integrity, and patient safety across Greek study sites.
Clinical Trial Manager
Clinical Trial Manager overseeing sponsor-dedicated clinical trials for ICON Strategic Solutions. Managing protocols, stakeholders, compliance, vendors, and study delivery.
Senior Clinical Research Associate
Senior Clinical Research Associate overseeing clinical trial monitoring, site management, and recruitment for Alimentiv. Home-based in Portugal with regular travel to sites in Portugal and Spain.
Principal Biostatistician, FSP
Principal Biostatistician leading clinical-trial design, analysis, and regulatory support for Cytel’s pharmaceutical clients. Applying advanced statistics, R, SAS, and simulation methods across Phase I-IV studies.