Clinical Site Specialist II - Remote U.S.

Job Overview

We are looking for a driven and experienced Clinical Site Specialist II to support and strengthen partnerships with site investigators, study teams, and other clinical trial stakeholders. The specialist will play a key role in site start-up and monitoring activities, ensuring trials proceed efficiently and with high quality standards.

Key Responsibilities

• Develop and maintain clinical site relationships involving investigators, site staff, and key opinion leaders (KOLs) for domestic and international trials managed by CRO partners.
• Foster collaborative working environments with stakeholders such as site investigators and research professionals.
• Work closely with multidisciplinary teams—including clinical operations, regulatory, and medical affairs—to guarantee smooth communication and coordination between sites and the company.
• Conduct site visits to promote company visibility, strengthen investigator partnerships, address site issues, and confirm compliance with protocols and ethical guidelines.
• Support protocol feasibility assessments and assist in site selection through feasibility questionnaires and pre-study evaluations.
• Contribute to development and implementation of site-specific plans, including investigator meetings, site initiation, recruitment and retention strategies, and quality monitoring.
• Evaluate site performance and proactively identify improvements to streamline trial processes and address operational or compliance challenges.
• Serve as a trusted advisor to investigators and study teams by guiding study design, protocol expectations, recruitment methods, and operational best practices.
• Coordinate with internal teams and vendors to exchange information and ideas that enhance clinical trial success and patient outcomes.
• Engage in Institutional Review Board (IRB) and Ethics Committee (EC) submissions and amendment reviews, including informed consent forms and site training materials.
• Assist in contract and budget negotiations for clinical trials and collaborate on vendor selection related to recruitment, home health, and patient logistics.
• Work with Clinical Project Management to facilitate site-vendor interactions for training, supply provision, sample tracking, query resolution, and issue management.
• Implement and oversee monitoring plans; review monitoring reports and ensure follow-up on actions; participate in monitoring oversight visits when necessary.

Qualifications

• Bachelor’s degree in a scientific or healthcare-related field.
• A minimum of three years of clinical research or operations experience, with expertise in site relationship management or related pharmaceutical/biotechnology roles.
• Strong knowledge of clinical trial operational procedures and regulatory frameworks including ICH-GCP and FDA guidelines, as well as international regulations (EU, APAC, LATAM).
• Proven ability to build durable relationships with site investigators, key stakeholders, and CROs.
• Capable of influencing without direct authority and skilled in negotiation across organizational levels.
• Analytical thinker with strong problem-solving skills and a dedication to decisions supported by data.
• Excellent verbal and written communication and presentation abilities, capable of simplifying complex concepts.
• Highly adaptable and resilient, able to thrive in a fast-paced and evolving environment.

Additional Information

This position is offered on a contract basis with remote work from within the U.S. Full-time employees may qualify for benefits including healthcare coverage, life and disability insurance, and 401(k) plans. The employer is an equal opportunity organization committed to diversity and inclusivity and provides accommodations for candidates with disabilities.