Clinical Research Associate
Veeda Lifesciences
- Tandil, Provincia de Buenos Aires Buenos Aires
- Permanente
- Tiempo completo
This is a full-time position.
Job overview :
The CRA is responsible for ensuring that the conduct of clinical trials at selected investigational sites complies with the approved protocol/amendments, ICH GCP guidelines, SOPs, and applicable laws and regulations.
He/she serves as the primary communication link for operational study activities between the Sponsor, Investigators, and study personnel to foster successful relationships.
The key responsibility is to ensure the rights of subjects are protected and that all clinical data collected are accurate, complete, and source-verifiable.
Main responsibilities :
Ensure compliance with the company's Quality and Information Security Management Systems, ICH GCP guidelines, local and international legislation, including data protection laws, and update as necessary.
Report deviations from protocols, guidelines, or legislation to the Line Manager according to SOPs.
Conduct pre-study visits for feasibility and site selection, assessing resources and facilities.
Collaborate with Regulatory Affairs and Clinical Operations for submissions and contracts, including hospital IEC submissions and approvals.
Prepare and maintain study documentation, ensuring proper collection of essential and study-related documents.
Supply study medication to sites, verify drug accountability, and oversee safe shipment, storage, and disposal.
Monitor clinical trial conduct by performing site visits, verifying protocol adherence, investigator qualifications, and data accuracy.
Ensure informed consent is obtained and documented appropriately.
Manage recruitment, timelines, and study supplies at sites.
Report safety information to the sponsor and ensure investigator training on adverse event reporting.
Ensure timely submissions to IEC/IRB and regulatory authorities.
Handle drug accountability and dispensation.
Document monitoring activities and communicate findings to investigators and management.
Participate in meetings, audits, and inspections, and facilitate corrective actions.
Assist in feasibility assessments, site selection, and study closure activities.
Support financial processes, including investigator payments.
Manage subject enrollment and data quality.
Contribute to departmental planning and SOP development.
Provide coaching and mentoring to less experienced CRAs.
Job Requirements :
Bachelor's or Master's degree in Health Sciences preferred.
Certified CRA.
6-12 months' CRA experience.
Fluent in English and Italian, both oral and written.
Experience with ICH GCP training (desirable).
Proficient in computer skills.
Strong communication, organizational, and interpersonal skills.
Ability to work independently and as part of a team.
Effective communication skills, diplomatic and assertive.
Capable of managing stressful situations and working under pressure.
Ability to handle multiple issues simultaneously.
Adherence to SOPs, guidelines, regulations, and ethical principles.
Willingness to travel frequently, including evenings and overnight stays.
Join our multidisciplinary team of scientists and healthcare professionals at the forefront of clinical research in a friendly environment.
We offer a competitive remuneration package.
We prioritize data protection and respect your privacy.
For details on data processing, please see our Privacy Notice to Candidates.
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