Clinical Research Associate – Immunology

This is a fully remote position, open to applicants in Florida, +3 more states.

📋 Description

• Responsible for the performance and compliance of assigned protocols and sites.

• Ensures that the conduct of the study adheres to ICH/GCP guidelines, country regulations, and our company's policies and procedures.

• Serves as the primary contact and site manager throughout all phases of a clinical research study.

• Develops and enhances the territory for clinical research by identifying and cultivating new sites.

• Conducts clinical study site management and monitoring activities in accordance with ICH-GCP, Sponsor SOPs, local laws and regulations, the protocol, the site monitoring plan, and related documents.

• Performs site visits and maintains clear, comprehensive, and accurate reports of both visit and non-visit contacts.

• Engages with investigators and site staff regarding issues related to protocol execution, recruitment, retention, regulatory documentation, and site audits/inspections.

• Identifies, evaluates, and resolves site performance, quality, or compliance issues.

⛳️ Requirements

• An Associate's degree, certificate, or equivalent in a scientific or healthcare discipline, along with a minimum of 5 years of relevant experience in the healthcare sector.

• At least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO, or a Bachelor’s degree (or higher) alongside at least 2 years of direct site management (monitoring) experience in a bio/pharma/CRO.

• Proficiency in local languages and English, both verbal and written.

• Solid understanding and working knowledge of clinical research, the phases of clinical trials, and current GCP/ICH and country-specific clinical research laws and guidelines.

• Demonstrated skills in site management, including the management of site performance and patient recruitment.

• Competent IT skills, including the use of MS Office and various clinical IT applications across computers, tablets, and mobile devices, with the ability to adapt to new IT applications.

• Capability to comprehend and analyze data/metrics and respond accordingly.

🏝️ Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate and sick leave days.