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Senior Clinical Research Associate (Argentina)

1 hour, 5 minutes ago
Argentina
Full-time
Senior
Project Manager
Project and Program Management
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 105

Description

  • Oversee all aspects of study site management to protect patient safety and maintain data quality.
  • Support audit readiness at the site and project level and assist with audit follow-up actions.
  • Establish, update, track, and maintain study management tools, systems, and status reports.
  • Manage site start-up activities, including feasibility, investigator recruitment, regulatory submissions, and informed consent review.
  • Support negotiation of study budgets and execution of investigator contracts when required.
  • Conduct pre-study, initiation, routine monitoring, close-out, and remote site visits in compliance with protocol, local laws, ICH-GCP, and SOPs.
  • Prepare and submit timely monitoring reports and other required project documentation.
  • Review investigator site files, reconcile them with the trial master file, and ensure essential documents are archived appropriately.
  • Communicate study issues, deviations, and corrective actions with site personnel and internal project teams.
  • Perform investigational product accountability, data review, query resolution, and serious adverse event processing.
  • Identify site risks, escalate issues, and drive timely resolution with project oversight.
  • Mentor, train, and support junior CRAs and new employees.

Requirements

  • 4-year college degree or equivalent experience in a scientific or healthcare discipline.
  • 5+ years of CRA experience in a CRO or pharmaceutical/biotech environment, or equivalent relevant experience.
  • Significant site management experience or equivalent clinical research experience.
  • Professional-level English proficiency, both written and verbal.
  • Graduate or postgraduate degree preferred.
  • Experience monitoring rare and complex therapeutic areas preferred.
  • Experience monitoring EDC trials and EHR records preferred.
  • Experience in biopharma or a relevant therapeutic area preferred.
  • Relevant site start-up experience in the country, including feasibility, contract negotiations, and submissions preferred.
  • Ability to monitor study sites according to protocol monitoring guidelines, SOPs, GCP, and ICH guidelines.
  • Ability to travel overnight, with up to 60% travel on average and international travel as needed.
  • Oncology experience, preferably in early phases, may be required for select opportunities.
  • Ability to work independently and in a team environment.
  • Strong presentation skills for colleagues, investigative staff, and clients.
  • Ability to prioritize workload, resolve project issues, and support continuous process improvement.

Benefits

  • Remote work arrangement indicated by the posting.
  • Opportunity to work across Latin America with support for studies in Argentina.
  • Exposure to complex and advanced clinical trial assignments.
  • Opportunity to mentor junior staff and develop leadership experience.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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