Clinical Trial Associate

About the Role:

We are looking for a highly motivated and detail-oriented Clinical Trial Associate to join our dynamic Clinical Operations team. Reporting to the Vice President of Clinical Operations, you will play a pivotal role in planning, executing, and managing clinical trials. This is an exciting opportunity to contribute to the development of life-changing treatments, while gaining exposure to various facets of clinical research in a collaborative and fast-paced environment.

As a Clinical Trial Associate, you will provide critical support throughout the clinical trial lifecycle, ensuring compliance with industry standards and driving forward clinical excellence. . With a focus on career development, you'll have the chance to grow within the organization and explore new avenues for advancement in Clinical Operations.

Key Responsibilities:

• Collaborate with Clinical Operations Teams: Assist and support Clinical Trial Managers in managing clinical trials, ensuring smooth execution from start-up to close-out.
• Build Strong Relationships: Liaise with clinical trial sites, vendors, CROs, and partners to maintain seamless communication and foster positive relationships.
• Streamline Processes: Support the team with administrative tasks, ensuring that all documentation is up-to-date and compliant with regulatory requirements.
• Review the Trial Master File (TMF): Ensure accurate and organized tracking of trial-related documentation, contributing to successful audits and regulatory submissions.
• Engage in Cross-Functional Communication: Prepare meeting agendas, track progress, create reports, and facilitate effective communication across all stakeholders.
• Drive Trial Success: Track clinical trial progress, from enrollment metrics to status updates, ensuring the project stays on target and within scope.
• Be a Resource for Study Teams: Proactively identify potential issues and collaborate with the study team to resolve them quickly, keeping trials on track.
• Ensure Compliance: Assist with the collection and processing of investigator site and regulatory documents, adhering to FDA and international regulatory standards (such as GCP and ICH).
• Support Logistics and Operations: Coordinate shipments of study-related materials, and ensure proper distribution to clinical sites.
• Maintain Study Documentation: Prepare and maintain essential documents, including clinical study files, regulatory binders, and operational manuals.
• Keep Department Organized: Help ensure smooth day-to-day operations by maintaining efficient filing systems, organizing clinical trial documentation, and supporting internal processes to optimize team productivity.
• Track Clinical Timelines Across Programs: Monitor and track clinical trial timelines across multiple programs, ensuring that all milestones are met in accordance with established schedules. Collaborate with teams to anticipate potential delays and take proactive measures to stay on track.

Why Join Us:

• Career Growth: At our company, your growth matters. This role offers ample opportunities to learn and advance your career in Clinical Operations.
• Impactful Work: Be part of a passionate team working on groundbreaking clinical trials that could shape the future of healthcare. Your contributions will have a direct impact on improving lives.
• Collaborative Environment: Work in a supportive and inclusive team where your voice is heard and your ideas matter. You'll have the chance to work alongside industry experts and build valuable relationships.
• Comprehensive Benefits: We offer a competitive salary, benefits package, and a dynamic work culture that prioritizes work-life balance.

Qualifications:

• Education & Experience: BA/BS in a related field or equivalent experience with 3 years in Clinical Operations (or equivalent experience without a degree).
• Knowledge: Strong understanding of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH).
• Technical Skills: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Personal Attributes: Ability to multitask, prioritize effectively, and maintain a keen attention to detail. Strong organizational and time management skills are essential.
• Communication Skills: Excellent written and verbal communication skills, with the ability to collaborate effectively across teams and stakeholders.

This is your opportunity to grow with a company that values your professional development and provides the tools and support for you to thrive in the fast-evolving field of clinical trials. We look forward to having you join our team!

The anticipated salary range for candidates who will work in South San Francisco, CA is $110,000 - $135,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location and relevant education or training. Septerna's compensation package also includes benefits, stock options, and annual target bonus for full-time positions.

Salary : $110,000 - $135,000