Senior Clinical Research Associate

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

📋 Description

• Establish, initiate, execute, monitor, and finalize IVD and medical device clinical trials at external clinical research facilities and/or laboratories.

• Independently train and oversee external clinical research sites.

• Supervise the execution of clinical study protocols from start to finish, ensuring timely data collection and adherence to FDA regulations and Good Clinical Practice.

• Build and sustain relationships with institutions, study investigators, internal stakeholders, and vendors.

• Perform independent study monitoring, which includes site coordination and accountability for investigational products.

• Evaluate protocol deviations and/or adverse events while enhancing clinical data quality.

• Follow up on incomplete data entries and outstanding inquiries.

• Manage IRB submissions and regulatory documentation for studies.

• Keep the Trial Master File current and prepared for audits.

• Participate in study planning, budget and contract negotiations, timeline forecasting, site identification and qualification, and process improvement initiatives.

• Prepare study documents and develop clinical templates, including informed consent forms and clinical monitoring plans.

⛳️ Requirements

• Bachelor’s degree with 5+ years of clinical research experience OR Master’s degree with 3+ years of clinical research experience OR Doctoral degree in a relevant field with clinical research experience.

• Fundamental knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products.

• Prior experience managing clinical research sites and monitoring clinical study data.

• Strong technical background to comprehend and communicate current and emerging technologies.

• Capability to handle multiple projects simultaneously.

• Willingness to travel 20-70%, including overnight trips, within the US.

• Experience in retrospective/prospective biological sample procurement is preferred.

• Familiarity with electronic Trial Master Files and Clinical Trial Management Systems is preferred.

• Proven understanding of CLSI standards and their application to IVD clinical studies is preferred.

🏝️ Benefits

• Health care program.

• Paid time off.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k).

• Bonus/incentive pay.

• Flexible, remote working arrangements for eligible positions.

• Work from home options available.