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

📋 Description

• Oversee relationships with investigator sites and the assigned clinical trial locations.

• Perform site initiation, continuous monitoring, remote/electronic assessments, and site closure activities.

• Ensure that clinical trials adhere to monitoring protocols, relevant laws, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and sponsor requirements.

• Act as the primary liaison for designated investigator sites while collaborating with study teams, vendors, and Site Care Partners.

• Offer coaching, training for site personnel, protocol education, and assistance with recruitment.

• Track adverse events and serious adverse events, working closely with the Drug Safety Unit.

• Submit documentation for the Trial Master File, including site reports, follow-up letters, protocol deviations, recruitment updates, supply management records, study progress, and metrics.

• Identify and address site-related issues, implementing corrective and preventive measures as needed.

• Resolve data inquiries and facilitate database releases.

• Manage the receipt, handling, accounting, storage, and disposal of investigational products.

• Support activities related to patient safety, eligibility, clinical guidance, quality issue remediation, audits, and Corrective and Preventive Action (CAPA) efforts.

• May assume unblinded monitoring duties when appropriate.

⛳️ Requirements

• Comprehensive understanding of clinical trial methodologies, ICH/GCP guidelines, FDA regulations, and local country laws.

• At least 2 years of relevant experience in monitoring clinical research sites.

• Proficiency in English and the native language(s) of the country in which you will be working is essential.

• Willingness to travel 60-80% of the time.

• A valid driver’s license and passport are necessary.

• A Bachelor’s degree in life sciences or a professional qualification in life sciences such as nursing, pharmacy, or a medical background, or an equivalent qualification.