Senior Clinical Research Associate

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

📋 Description

• Supervise the management and monitoring activities of clinical trial sites to ensure adherence to ICH-GCP, regulatory guidelines, and company SOPs.

• Collaborate closely with clinical sites and cross-functional teams to facilitate the successful execution of studies, enhance patient recruitment, and achieve operational excellence throughout clinical trials.

• Carry out all clinical monitoring tasks, including site qualification, initiation, routine monitoring, and close-out visits.

• Assist in site feasibility assessments, site selection, and ongoing management activities throughout the clinical trial lifecycle.

• Evaluate clinical trial progress, patient recruitment, and data quality metrics, implementing necessary actions to meet study objectives.

• Ensure accurate and timely monitoring documentation is maintained, including trip reports and trial master file records.

• Work in partnership with vendors, clinical sites, and cross-functional teams to support study execution and maintain operational compliance.

• Engage in investigator meetings, development of clinical trial documentation, and study team meetings.

• Provide mentorship to junior CRA team members and contribute to the continuous enhancement of clinical operations processes and procedures.

⛳️ Requirements

• Bachelor’s degree in life sciences, nursing, or a related discipline.

• Over 4 years of on-site monitoring experience in the pharmaceutical or biotechnology sectors, encompassing all types of clinical monitoring visits.

• In-depth knowledge of ICH-GCP, FDA, EMA, and relevant clinical trial regulations.

• Proven experience in managing clinical trial sites, overseeing monitoring activities, and maintaining clinical trial documentation.

• Proficiency in utilizing clinical trial systems and tools (e.g., CTMS, eTMF, Microsoft Office).

🏝️ Benefits

• Competitive rates for Health, Dental, and Vision Insurance.

• Four weeks of vacation, provided upfront each year and prorated for the first and last year of employment.

• Twelve company-paid holidays.

• Seven days of sick leave.

• 100% employer-paid life insurance up to 1x annual salary, capped at one hundred thousand dollars.

• 100% employer-paid short- and long-term disability coverage.

• 401(k) plan with immediate eligibility and company matching… The company matches 100% of your contributions up to 3% of your base salary for the first two years, 4% for years 2-3, and up to 5% of your salary from the fourth year of continued employment onward.

• Partially paid parental leave for eligible employees.

• Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance.