Clinical Research Associate

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

📋 Description

• Assess the clinical trial resource needs for qualification (SQVs), training (SIVs), monitoring (IMVs), and site support during trial execution.

• Collaborate with various trial sites and multiple studies across different indications simultaneously.

• Create and maintain a comprehensive monitoring plan for assigned clinical trial(s).

• Communicate with external clinic and/or hospital investigators and their teams as necessary to ensure alignment with study and monitoring expectations from initiation to completion.

• Supervise the setup of trial sites, ensuring that each location has the necessary materials to conduct the study.

• Manage the site activation processes for each study.

• Develop and track metrics to assess monitor and site performance, addressing any performance issues and mitigating risks to the study as needed.

• Regularly review data to detect potential issues or discrepancies that may indicate problems with data collection or monitoring.

• Monitor patient enrollment and suggest strategies to trial site staff to enhance the recruitment of qualified subjects.

• Assist in the resolution of data queries, deviations, adverse events, etc.

• Prepare monitoring visit reports.

• Formulate and implement a strategy for closing trial sites upon completion of the study and carry out related close-out activities.

• Ensure compliance with ICH-GCP, Standard Operating Procedures (SOPs), IRB regulations, and study protocols.

• Guarantee regulatory adherence for investigational sites with SOPs, FDA regulations, and ICH guidelines.

• Coordinate with the team on data management tasks.

• Draft protocols and Informed Consent documents for management evaluation.

• Conduct Literature Reviews for new study indications.

• Support the development of Case Report Forms (CRFs).

• Assist in organizing investigator meetings.

• Produce study status data tables and slide presentations for upper management review.

• Establish and maintain study site investigator binders from the start to the conclusion of the study.

• Keep up-to-date knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, and other pertinent regulations/standards, along with internal policies and SOPs.

• Begin job responsibilities promptly and maintain a consistent presence throughout the entire shift to fulfill duties effectively and attend all scheduled meetings and appointments.

• Be flexible to work beyond normal business hours during weekdays or weekends with appropriate advance notice to meet business/operational needs when necessary.

• Carry out other assigned duties.

⛳️ Requirements

• A bachelor's degree is required, preferably in Clinical Research, Life Sciences, or a related discipline.

• Certification as a Clinical Research Associate (CRA), such as CCRA, CCRP, or other CRA certifications is strongly preferred.

• A minimum of 3 years of relevant experience in the industry or experience working with Sponsor companies as a clinical coordinator is required.

• Previous experience in study supervision is required.

• A favorable background investigation clearance is required.

• A valid Class “C” driver’s license is necessary.

• This role requires up to 50% travel.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health benefits package including medical, dental, and vision coverage.

• Opportunities for professional development and continuing education.

• Flexible work hours and remote work options.

• Supportive work environment with a strong team culture.