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Quetzal Therapeutics · 2 months ago

Clinical Trial Associate

Chicago, IL

Full-time

Hybrid

Entry Level

1+ years exp

Quetzal Therapeutics is a biopharmaceutical company focused on developing treatments for rare diseases, including hematologic malignancies. They are seeking a Clinical Trial Associate to support clinical activities across vendors, CROs, and sites, ensuring document quality and audit readiness while working under moderate supervision.

BiopharmaHealth CareMedical

Responsibilities

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

Qualification

Clinical Operations experienceFDAEMA RegulationsICH GuidelinesMS Office proficiencyProject tracking toolsOncology experienceCommunication skillsTeamwork skillsAttention to detailOrganizational skills

Required

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%)