This is a fully remote position, open to applicants in Florida.

📋 Description

• Act as the main liaison between investigational sites and the sponsor.

• Perform site selection, initiation, regular monitoring, and closure visits.

• Ensure compliance of sites with ICH-GCP, SOPs, and relevant regulations.

• Maintain accurate documentation within CTMS and eTMF systems.

• Provide training support for site staff and keep compliance records updated.

• Oversee patient safety and manage reporting of AEs/SAEs/PQCs.

• Assist with subject recruitment and retention efforts.

• Supervise drug accountability and its proper storage, return, or disposal.

• Address data queries and ensure prompt, high-quality data entry.

• Record site progress and escalate any risks or issues as necessary.

• Help manage site budgets and payment processes.

• Collaborate effectively with CTAs, LTMs, and CTMs.

⛳️ Requirements

• Bachelor’s degree in Life Sciences or an equivalent qualification, or a qualified RN.

• Must be eligible to work in the United States without the need for visa sponsorship.

• A minimum of 3 years of on-site monitoring experience in the pharmaceutical or CRO sector.

• Experience in monitoring across various therapeutic areas.

• Strong knowledge of ICH-GCP, local regulatory standards, CTMS, and eTMF.

• Excellent communication, problem-solving, and teamwork abilities.

• Must be willing and able to travel 60%–75% for on-site monitoring visits throughout the southeastern region.

• Preference will be given to candidates living in Florida near major HUB airports.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans available.

• Life insurance and disability coverage provided.

• Employee assistance programs and resources for wellbeing.

• Opportunities for learning and development through structured training and career pathways.