Sr. Clinical Research Associate

About the role

As a Senior Clinical Research Associate at Structuretx, you will play a role in the management and execution of clinical trials aimed at advancing innovative therapies. This position requires a deep understanding of clinical research processes, regulatory requirements, and the ability to work collaboratively within a dynamic team environment. You will be responsible for overseeing study sites, ensuring compliance with protocols, and contributing to the overall success of clinical projects that have the potential to transform patient care.

Key facts

What you'll do

• Lead the planning and execution of clinical trials, ensuring adherence to study protocols and regulatory guidelines.
• Monitor clinical sites to ensure compliance with Good Clinical Practice (GCP) and applicable regulations, conducting regular site visits and audits.
• Collaborate with cross-functional teams, including project managers, data managers, and medical monitors, to facilitate effective communication and project progress.
• Develop and maintain strong relationships with site personnel, providing guidance and support throughout the study lifecycle.
• Assist in the preparation of study-related documents, including protocols, informed consent forms, and study reports.
• Review and approve site-specific materials, ensuring alignment with the overall study objectives and regulatory requirements.
• Manage the collection, tracking, and reporting of clinical trial data, ensuring accuracy and completeness.
• Identify and resolve issues that may arise during the study, implementing corrective actions as necessary to maintain study integrity.
• Participate in training and mentoring junior staff and site personnel on clinical trial processes and best practices.
• Contribute to the development of clinical trial budgets and timelines, ensuring projects are delivered on time and within budget.
• Stay current with industry trends and regulatory changes, applying this knowledge to enhance clinical trial operations.
• Prepare for and participate in regulatory inspections and audits, ensuring all documentation is in order and readily accessible.

Requirements

• Bachelor's degree in life sciences, nursing, or a related field; advanced degree preferred.
• A minimum of 5 years of experience in clinical research, with a focus on monitoring and managing clinical trials.
• In-depth knowledge of GCP, ICH guidelines, and FDA regulations.
• Proven track record of managing multiple clinical trials simultaneously, demonstrating strong organizational skills.
• Excellent communication and interpersonal skills, with the ability to build rapport with diverse stakeholders.
• Strong analytical skills, with the ability to interpret complex data and make informed decisions.
• Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) tools.
• Ability to work independently and as part of a team, demonstrating flexibility and adaptability in a fast-paced environment.

Nice to have

• Certification as a Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) is a plus.
• Experience in therapeutic areas relevant to Structuretx's pipeline, such as oncology or rare diseases.
• Familiarity with project management methodologies and tools.
• Previous experience in a start-up or biotech environment is advantageous.

Skills & tools

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and data analysis software.
• Familiarity with electronic clinical trial management systems (e.g., Medidata, Veeva).
• Strong understanding of data management processes and statistical analysis.
• Excellent problem-solving skills and attention to detail.

Practical notes

• This position is based in South San Francisco, California, and may require occasional travel to clinical sites.
• Candidates must be eligible to work in the United States; visa sponsorship is available for qualified individuals.
• Structuretx offers a competitive benefits package, including health insurance, retirement plans, and opportunities for professional development.

Join Structuretx as a Senior Clinical Research Associate and contribute to research that has the potential to change lives. If you are about clinical research and eager to make a difference, we encourage you to apply through our careers page.

About the company

Medicine is our platform. Accessibility is our cure.