Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals

Health Care

251-1K (427)

Founded 2012

142 open positions

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Senior Clinical Research Associate (Argentina)

1 hour, 6 minutes ago

Latin America, Argentina

Full-time

Senior

Project Manager

Project and Program Management

GCP

Apply Now

Precision Medicine Group

Pharmaceuticals

251-1K

Founded 2012

View All Jobs 142

Description

Independently oversee all aspects of study site management to protect patient safety and maintain high-quality data.
Provide site- and project-level guidance on audit readiness and support audit preparation and follow-up actions.
Establish, update, track, and maintain study-specific trial management tools, systems, and status reports.
Manage site start-up activities, including feasibility, investigator recruitment, EC/IRB submissions, regulatory document review, and informed consent adaptation.
Support negotiation of study budgets and execution of investigator contracts when required.
Conduct pre-study, initiation, routine monitoring, and close-out visits in accordance with protocol, local laws, ICH-GCP, and SOPs.
Prepare and submit accurate monitoring reports and document site activities through required letters, logs, trip reports, and project documents.
Support subject recruitment, retention, and awareness efforts, and enter tracking data to manage observations and action items.
Review and reconcile Investigator Site Files and Trial Master Files, ensuring essential documents are archived appropriately.
Communicate site issues, deviations, and required actions with site personnel and project teams, and maintain strong investigator and staff relationships.
Perform investigational product inventory, reconciliation, storage, security, labeling, import, release, and return activities.
Review remote EDC CRFs and patient profiles, resolve queries, and assist with data discrepancies and clinical data quality issues.
Identify and process Serious Adverse Events in accordance with study procedures.
Escalate site risks to the Clinical Trial Manager or Project Manager and drive timely resolution.
Mentor and train junior staff, assist with presentations and training materials, and support team managers with protocol and study document review.

Requirements

4-year college degree or equivalent experience in a scientific or healthcare discipline.
5 or more years of experience as a CRA in a CRO or pharmaceutical/biotech environment, or equivalent relevant experience.
Significant site management experience or equivalent clinical research experience.
Professional-level English communication skills, both verbal and written.
Graduate or postgraduate degree is preferred.
Experience monitoring rare and complex therapeutic areas is preferred.
Experience monitoring EDC trials and EHR records is preferred.
Experience in biopharma or a relevant therapeutic area is preferred.
Relevant site start-up experience in the country, including feasibility, contract negotiations, and submissions, is preferred.
Ability to monitor study sites with supervision according to protocol monitoring guidelines, SOPs, GCP, and ICH guidelines is preferred.
Ability to resolve project-related problems and prioritize workload to meet deadlines, with management oversight, is preferred.
Ability to travel overnight, with up to 60% travel on average and international travel as needed.
Oncology experience, preferably in early-phase studies, is required for select opportunities.
Self-motivation and the ability to work independently and in a team environment are preferred.
Working knowledge of clinical trial methodology, protocols, and study indications is preferred.
Ability to conduct formal presentations to colleagues, investigative staff, and clients is preferred.
Demonstrated focus on continuous improvement and process efficiency is preferred.

Benefits

Remote work designation is indicated by the posting.
Opportunity to support studies across Argentina and Latin America.
Equal Opportunity Employer status and nondiscrimination in hiring.
Reasonable accommodation support for applicants with disabilities during the application process.

Interested in this position?

Apply directly on the company website

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