Quetzaltx
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.
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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.
#J-18808-Ljbffr