Senior Clinical Research Associate, Field Monitor

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

📋 Description

• Conduct site selection, initiation, routine monitoring, and closure visits for designated clinical trial sites.

• Perform remote, risk-based, and on-site monitoring, which includes source data verification and accountability reconciliation of investigational products.

• Identify and mitigate risks in accordance with ICH E6(R3) and Risk-Based Quality Management principles.

• Assess site metrics and address any deviations identified.

• Analyze study protocols, procedures, logistics, and risks related to research subjects.

• Act as a subject matter expert for clinical sites, providing guidance on protocol, eligibility, and safety reporting.

• Ensure the accuracy, validity, and completeness of the data collected.

• Review Case Report Form data and resolve complex queries related to data.

• Utilize protocol deviations as indicators to initiate retraining processes.

• Oversee the collection and maintenance of essential documents within the electronic Trial Master File.

• Implement recruitment and retention strategies, focusing on diversity, equity, and inclusion best practices.

• Create, review, and update training materials related to the study.

• Coordinate logistics for investigational product supply, manage temperature excursions, and oversee clinical specimen logistics.

• Contribute to audit and inspection preparation while driving the development of CAPA.

• Mentor and train new field and in-house Clinical Research Associates (CRAs).

• Engage in ad-hoc and cross-functional duties and projects.

⛳️ Requirements

• A Bachelor’s degree in clinical research, science, or a health-related discipline is required.

• Alternatively, a Registered Nurse with at least 5 years of on-site monitoring experience may substitute for a Bachelor’s degree.

• A minimum of 6 years of experience in clinical trials within pharmaceutical, biotechnology, CRO, or healthcare environments is essential.

• At least 4 years of independent on-site and remote monitoring experience is required.

• A current valid driver’s license is necessary.

• Advanced knowledge of the drug development process and medical terminology is expected.

• Familiarity with current ICH-GCP E6(R3) principles and the Code of Federal Regulations is required.

• High proficiency in EDC, eTMF, CTMS, MS Office Suite, and Adobe is necessary.

• Strong written, verbal, and persuasive presentation skills in English are essential.

• Excellent organizational skills, ability to multitask, detail orientation, and time management capabilities are required.

• Ability to make data-driven decisions and provide guidance on complex issues is important.

• Capacity to build trust across functions, maintain composure under pressure, and demonstrate an inclusive mindset is necessary.

• Adherence to company Standard Operating Procedures and corporate confidentiality is expected.

• Willingness to travel 50–75% of the time, including overnight travel, is required.

• Ability to successfully pass a motor vehicle record check upon hiring and annually thereafter is necessary.

🏝️ Benefits

• Discretionary bonus.

• Equity award.

• Options for Medical, Dental, and Vision Plans.

• Health and Financial Wellness Programs.

• Employer Assistance Program (EAP).

• Company Paid and Voluntary Life/AD&D.

• Short-Term and Long-Term Disability coverage.

• Flexible Spending Accounts for Healthcare and Dependent Care.

• 401(k) Retirement Plan with Company Match.

• 529 Education Savings Program.

• Voluntary Legal Services.

• Identity Theft Protection.

• Pet Insurance.

• Employee Discounts, Rewards, and Perks.

• Paid Time Off (PTO), including 11 Holidays.

• Unlimited PTO for exempt employees.

• For non-exempt employees: 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days, and 1 Cultural Day.

• Flexible hours to accommodate various time zones and site locations.

• Opportunities for professional development.