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

📋 Description

• Oversee the advancement of clinical studies at investigative sites or through remote monitoring.

• Ensure that clinical trials are executed, documented, and reported in accordance with the protocol, SOPs, ICH-GCP, and relevant regulatory standards.

• Carry out site qualification, initiation, monitoring, and close-out visits as per monitoring plans, sponsor and company SOPs, ICH/GCP guidelines, and applicable laws.

• Engage in investigators’ meetings.

• Draft site visit reports and follow-up correspondence for investigators.

• Foster productive relationships with investigators and site personnel to fulfill study goals, including patient recruitment objectives.

• Perform verification of source data.

• Ensure proper on-site storage, dispensing, and accountability of study drugs.

• Confirm that data collection and regulatory documentation are sufficient.

⛳️ Requirements

• Bachelor's degree in a relevant field to clinical research, nursing degree, and/or equivalent experience.

• 5 to 8 years of experience in conducting on-site clinical monitoring in the biotechnology, pharmaceutical, and/or contract research organization (CRO) field.

• Strong understanding of ICH/GCP standards and relevant regulatory requirements.

• Excellent verbal and written communication skills in English.

• Ability to manage multiple assignments and work under pressure while maintaining meticulous attention to detail and adhering to deadlines.

• Exceptional judgment and problem-solving capabilities.

• Willingness to travel to research sites approximately 65% of the time.

• Proficient in Microsoft Office applications (i.e., Word, Excel, PowerPoint).

• Experience in dermatology is a plus.

• Applicants must have legal authorization to work in the US.