Sr CRA - Ophthalmology Experience Required (Home-based, Argentina)

Syneos Health; Buenos Aires; Teletrabalho; USD 60.000 - 90.000; Tempo integral

Resumo da oferta

Syneos Health is seeking a Senior Clinical Research Associate (Sr CRA) with experience in ophthalmology. This full-time, home-based position involves site qualification, monitoring, and compliance management. Ideal candidates will have a background in clinical operations and valid qualifications such as a Bachelor’s degree or RN, along with strong communication skills. Join a dedicated team focused on enhancing patient outcomes through innovative biopharmaceutical solutions.

Serviços

Opportunities for career development

Inclusive culture

Diverse environment

Qualificações

• Bachelor’s degree or RN required.
• Proficient in GCP/ICH guidelines.
• Excellent communication skills.

Responsabilidades

• Perform site qualification, initiation, and monitoring visits.
• Conduct source document reviews and verify data accuracy.
• Manage investigational product inventory and ensure compliance.

Conhecimentos

Communication

Interpersonal skills

Data integrity

Problem-solving

Regulatory compliance

Formação académica

Bachelor’s degree or RN in a related field

Ferramentas

Computer systems

Descrição da oferta de emprego

Sr CRA - Ophthalmology Experience Required (Home-based, Argentina)

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Job Summary

Syneos Health is a leading fully integrated biopharmaceutical solutions organization committed to accelerating customer success. We focus on translating clinical, medical affairs, and commercial insights into meaningful outcomes. Our Clinical Development model centers on the customer and patient, aiming to simplify and streamline processes to enhance our service and work environment. Join our passionate team of problem solvers dedicated to changing lives.

Why Work Here

• Opportunities for career development, training, and recognition
• A supportive, inclusive culture embracing Total Self where you can be authentic
• A diverse environment fostering innovation and belonging

Responsibilities

• Perform site qualification, initiation, monitoring, management, and close-out visits (on-site or remote), ensuring compliance with regulatory standards, ICH-GCP, and protocols. Evaluate site performance and escalate issues as needed.
• Verify informed consent processes, protect patient confidentiality, and assess safety and data integrity concerns.
• Conduct source document reviews, verify data accuracy, apply query resolution techniques, and support data management activities.
• Manage investigational product inventory, reconciliation, and storage, ensuring proper dispensing and compliance with protocols.
• Review and ensure accuracy of the Investigator Site File and Trial Master File, and support audit readiness.
• Document activities, support patient recruitment and retention strategies, and track progress using appropriate systems.
• Coordinate with project teams to meet scope, budget, and timeline goals, and adapt to changing priorities.
• Act as liaison with site personnel, ensuring training and compliance, and participate in meetings and training sessions.
• Support audit preparation and follow-up, and mentor junior CRAs as needed.
• For Real World Late Phase studies, provide site support, collaborate with regulatory teams, and participate in bid defense meetings.

Qualifications

• Bachelor’s degree or RN in a related field, or equivalent experience
• Knowledge of GCP/ICH guidelines and applicable regulations
• Proficiency with computer systems and new technologies
• Excellent communication, presentation, and interpersonal skills
• Willingness to travel up to 75% regularly

Additional Information

Tasks and responsibilities are not exhaustive and may change. Equivalent experience and skills will be considered. The company is committed to compliance with applicable laws and regulations, including ADA accommodations.

Job Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Research and Science

Learn more about us at syneoshealth.com