Senior Contract CRA — Remote Clinical Monitoring

Ergclinical; Northern (KY); Hybrid; USD 90,000 - 120,000; Part time

Job summary

Lotus Clinical Research is seeking a Contract Senior Clinical Research Associate to conduct site monitoring for multicenter trials. You will ensure protocol adherence, manage site visits, and maintain audit-ready documentation in a remote US setting.

Ideal candidates have a life sciences background with CRA II experience and strong knowledge of GCP, ICH guidelines, and FDA regulations. Travel up to 100% may be required.

Qualifications

• Expert knowledge of drug development processes and regulatory guidelines.
• Experience applying ICH and GCP in clinical trials.
• Proven ability to monitor site activities and ensure quality data.
• Ability to work independently and travel up to 100%.

Responsibilities

• Monitor clinical sites for assigned trials per SOPs, FDA regulations, and GCP.
• Coordinate site qualification, initiation, interim monitoring, and close-out visits.
• Ensure documents are audit-ready and uploaded to the Trial Master File.
• Communicate with sites, resolve queries, and manage study data flow.

Skills

Drug development process

ICH guidelines

GCP

Clinical trial experience

Education

Bachelor's degree in life sciences or healthcare

Mastery of CRA II responsibilities

Tools

Electronic CRF platforms

Job description

Lotus Clinical Research is seeking a Contract Senior Clinical Research Associate to conduct site monitoring for multicenter trials. You will ensure protocol adherence, manage site visits, and maintain audit-ready documentation in a remote US setting.

Ideal candidates have a life sciences background with CRA II experience and strong knowledge of GCP, ICH guidelines, and FDA regulations. Travel up to 100% may be required.