Clinical Research Associate

$62,400 - $120,640/Yr

Biotech Careers - Austin, TX

Full-time - Entry Level

Austin, TX

Administrative and Support Services

About the position

Clinical Research Associates (CRAs) play a crucial role in conducting studies that examine the safety and efficacy of new drugs in human patients, commonly referred to as clinical trials. These professionals are responsible for ensuring that clinical trials are conducted in compliance with Good Clinical Practices (GCP) and the International Conference on Harmonization (ICH) guidelines. Their work involves managing and overseeing clinical study sites to guarantee data quality and patient safety, adhering to local regulations and applicable Standard Operating Procedures (SOPs). CRAs are often involved in the administrative aspects of site selection, study implementation, and ongoing coordination of study sites, either directly or through Clinical Research Organizations (CROs). The responsibilities of a Clinical Research Associate include monitoring study sites, performing routine data collection from patients, verifying data sources, and reviewing regulatory documents to ensure compliance with protocols, regulatory requirements, and SOPs. They may assist in reviewing study protocols, informed consent forms, and case report forms, and may also participate in developing monitoring plans, abstracts, presentations, manuscripts, and clinical study reports under supervision. This position is ideal for individuals transitioning from nursing careers, as it often requires a background in clinical experience or nursing, along with a strong understanding of clinical research methodologies and data management practices.

Responsibilities

• Conduct studies to examine the safety and efficacy of new drugs in human patients.
• Manage and oversee clinical study sites to ensure data quality and patient safety.
• Ensure compliance with Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
• Provide administrative assistance in site selection, study implementation, and ongoing coordination of study sites.
• Monitor study sites and perform routine data collection from patients.
• Verify data sources and review regulatory documents/files for compliance with protocols and regulatory requirements.
• Assist in reviewing study protocols, informed consent forms, and case report forms.
• Participate in developing monitoring plans, abstracts, presentations, manuscripts, and clinical study reports under supervision.

Requirements

• Bachelor's degree in a scientific discipline or equivalent.
• 2 years of previous clinical experience or nursing experience is often required.
• Working knowledge of International Conference on Harmonization Good Clinical Practice guidelines (ICH-GCP).
• Excellent verbal and written communication skills.
• Strong organizational, multi-tasking, and time management skills.
• Experience with Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (e.g., CTMS, EDC, eTMF).
• Ability to travel as required (50-75%).
• Detail-oriented with strong observational skills.

Nice-to-haves

• Previous clinical research experience is preferred.
• Experience in remote monitoring visits.

Benefits

• Competitive hourly pay ranging from $30 to $58.
• Annual salary range of $80,000 to $120,000 depending on experience and qualifications.