Clinical Research Associate II - Argentina

Worldwide Clinical Trials; Tandil; À distance; ARS 900 000 - 1 300 000; Plein temps

Résumé du poste

Worldwide Clinical Trials seeks a Clinical Research Associate to oversee site qualification, initiation, monitoring, and close-out visits within Argentina. You will ensure patient safety, data quality, and regulatory compliance while coordinating with investigative sites and sponsor teams.

The role requires MD/Pharmacy or equivalent degree with CRA experience, strong knowledge of GCP/ICH or FDA/EU regulations, and proficiency with EDC systems, MS Office, and IxRS.

Qualifications

• Education and experience: MD or Pharmacy degree (MSPH, PharmD, PhD, or equivalent) with at least one year of CRA Level I experience; OR a four-year degree in medical/biological/health/science with two years of CRA experience; OR two-year college with two years of CRA experience.
• Strong knowledge of clinical research principles, GCP, ICH, FDA/EU regulations, and SOPs.
• Experience across 3–5 therapeutic areas or depth in 2–3 areas.
• Proficiency with MS Office, IxRS, and EDC systems.

Responsabilités

• Conduct site qualification, initiation, interim monitoring, and close-out visits per protocol and GCP.
• Monitor study conduct, source data, informed consent, and safety information.
• Assess and train site staff on protocol requirements and issues.
• Ensure regulatory and site documentation is complete and maintained.
• Coordinate data queries and safety-event reporting with sites.
• Oversee investigational product receipt, accountability, and destruction.
• Maintain clear, timely visit reports and communicate with sites.
• Contribute to protocols, CRFs, monitoring plans, and feasibility studies.
• Assist in training other CRAs on accompanied site visits.

Connaissances

Clinical research knowledge

GCP & regulations

EDC systems

English + local language

Travel readiness

Formation

MD/Pharmacy degree

Four-year life sciences degree

Nursing degree

Outils

IxRS

Microsoft Office

Description du poste

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research. Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life-changing therapies to patients around the world.

With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

Make an Impact as a Clinical Research Associate at Worldwide

As a Clinical Research Associate, you’ll play a key role in protecting patient safety and data quality throughout the clinical trial lifecycle. You’ll work closely with investigative sites to ensure studies are conducted in line with protocols, Good Clinical Practice (GCP), applicable regulations, and study requirements.

• Conduct site qualification, initiation, interim monitoring, and close-out visits in accordance with study protocols, GCP, applicable regulations, and SOPs.
• Monitor study conduct, source documentation, informed consent, subject safety information, and CRFs to support patient safety and data quality.
• Assess and train site staff on protocol requirements and address compliance or study-related issues as needed.
• Ensure regulatory, ethics, and site documentation is complete, current, and appropriately maintained for the Investigator Site File and Trial Master File.
• Partner with sites to resolve data queries, maintain timely data submission, and ensure appropriate safety-event reporting and follow-up.
• Oversee study materials and investigational product receipt, accountability, return, or destruction at assigned sites.
• Maintain regular communication with investigative sites and document monitoring activities and findings through clear, timely visit reports.
• Contribute input to protocols, CRFs, monitoring plans, and feasibility activities as requested.
• Support the assessment and training of other CRAs through accompanied site visits when appropriate.

Where You'll Work

This is a home-based Clinical Research Associate role supporting sites across Argentina. Candidates must reside within the territory to effectively support site visits and study activities. You will collaborate with sites, sponsors, and global study teams while traveling to investigative sites approximately 6-10 days per month.

To best support our sites, we're seeking candidates who are based in Argentina. Travel will primarily be regional, with occasional travel to support sites in other locations as needed.

What You'll Do

• Conduct site qualification, initiation, interim monitoring, and close-out visits in accordance with study protocols, GCP, applicable regulations, and SOPs.
• Monitor study conduct, source documentation, informed consent, subject safety information, and CRFs to support patient safety and data quality.
• Assess and train site staff on protocol requirements and address compliance or study-related issues as needed.
• Ensure regulatory, ethics, and site documentation is complete, current, and appropriately maintained for the Investigator Site File and Trial Master File.
• Partner with sites to resolve data queries, maintain timely data submission, and ensure appropriate safety-event reporting and follow-up.
• Oversee study materials and investigational product receipt, accountability, return, or destruction at assigned sites.
• Maintain regular communication with investigative sites and document monitoring activities and findings through clear, timely visit reports.
• Contribute input to protocols, CRFs, monitoring plans, and feasibility activities as requested.
• Support the assessment and training of other CRAs through accompanied site visits when appropriate.

What You'll Bring

• Education and experience: MD or Pharmacy degree (MSPH, PharmD, PhD, or equivalent) with at least one year of experience as a Clinical Research Associate Level I; OR a four-year degree focused on medical, biological, physical, health, pharmacy, or a related science with at least two years of clinical research experience; OR a two-year college curriculum or equivalent education/training, preferably nursing or life sciences, with two years of experience as a Clinical Research Associate Level I.
• Strong knowledge of clinical research principles and processes, GCP, ICH Guidelines, applicable FDA and/or EU regulations, local regulatory requirements, and SOPs.
• Clinical research knowledge across three to five therapeutic areas, or in-depth knowledge of two to three therapeutic areas.
• Proficiency with Microsoft Office, IxRS, and electronic data capture (EDC) systems.
• Excellent communication, organisation, time-management, interpersonal, initiative, and problem-solving skills, with the ability to work independently in an organised and methodical way.
• Proficiency in spoken and written English, together with fluency in the local languages of the countries under responsibility.
• Valid current passport and driving licence, with willingness to travel as required.
• Experience in full-service monitoring PREFERRED

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials.