Clinical Trial Associate

Quetzal Therapeutics is a biopharmaceutical company focused on the development of treatment for rare diseases including hematologic malignancies. The company’s lead product is QTX-2101, a novel paradigm for treating patients with Acute Promyelocytic Leukemia (APL). The company plans to initiate Phase III clinical trials by late-2025, with enabling activities ongoing. Quetzal is also developing a pre-clinical asset QTX-2102, an advanced, next-generation antifungal and antiparasitic therapy designed to enhance efficacy while minimizing toxicity.

About the role

This is a unique opportunity for a Clinical Trial Associate (CTA). You will be responsible for supporting the execution of clinical activities across vendors, CROs, and sites from start-up through close-out with growing independence. This position will report into the Director of Clinical Operations.

What you’ll do

• Work on problems of a moderate scope, using independent decision-making to select course of action within described guidelines under moderate supervision..
• Maintain tracking systems (e.g., site status, enrollment metrics); assist with study start-up activities (e.g., site feasibility, essential document collection).
• Arrange meeting logistics, agendas, and meeting minutes
• Interact with the study team, as directed, to complete moderate tasks; interface with vendors and site personnel as needed.
• Ensure document quality and audit readiness in Trial Master File (TMF)
• With moderate supervision from the study lead (or designee), support the review of study documents such as protocols, informed consent forms (ICFs), case reports forms (CRFs), monitoring plans, etc.
• Interface with vendors (e.g., central labs, CROs) and site personnel as needed and with limited supervision from the study lead (or designee).
• Support other Clinical Operations activities as appropriate.

Required Skills, Experience and Education:

• BS, BA, or RN in a relevant scientific discipline.
• 1-3 years of relevant experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research related experience.
• Knowledge of FDA and EMA Regulations, ICH Guidelines, GCP, and familiarity with standard clinical operating procedures.
• Good communication and teamwork skills.
• Proficient in MS Office and project tracking tools.
• Strong attention to detail and organization, demonstrate reliability and efficiency in supporting clinical trial operations .
• Take the initiative to independently apply knowledge of Clinical Operations.
• Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.
• High sense of urgency and commitment to excellence in the successful execution of deliverables.
• Ability to multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.
• Travel may be required (~10%).

Preferred Skills:

• Has familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
• Oncology experience, early and/or late stage, strongly preferred.