Clinical Trial Associate

Sitero LLC•Coral Gables, FL

1d•Hybrid

About The Position

The Clinical Trial Associate (CTA) supports the execution of clinical trials by ensuring study documentation, site management activities, and data quality standards are maintained in alignment with ICH GCP, applicable regulations, and sponsor requirements. This is an excellent opportunity for an early-career clinical research professional to grow within a dynamic, technology-driven CRO environment.

Requirements

Bachelor's or Master's degree in Life Sciences, Nursing, Pharmacy, or a related field from an accredited university.
Minimum 1 year of experience in a CRO, pharmaceutical, or biotech environment; internship or co-op experience in clinical research considered.
Working knowledge of ICH GCP guidelines and clinical trial regulatory requirements.

Nice To Haves

Proficiency with Microsoft 365 (Word, Excel, Outlook, Teams).
Experience with EDC systems such as Medidata Rave or similar platforms.
Familiarity with Clinical Trial Management Systems (CTMS) and eTMF platforms.
Strong organizational skills and attention to detail with the ability to manage multiple priorities in a remote environment.
Effective written and verbal communication skills.

Responsibilities

Provide high-quality support in managing and overseeing clinical trials in accordance with ICH GCP guidelines, applicable regulations, company and sponsor SOPs, project plans, and local regulatory requirements.
Support Clinical Trial Managers with project-related activities and deliverables, including contract and budget activities as required.
Manage essential document collection and review throughout the study lifecycle; organize and maintain site Trial Master File (TMF) documents and site-related data in applicable clinical systems per record retention procedures.
Perform Informed Consent Form (ICF) customization in compliance with applicable guidelines and local regulatory requirements.
Support the setup, data entry, and quality control of clinical systems to ensure accuracy and integrity of study data.
Assist with new trial submissions, including protocol updates to Institutional Review Boards (IRBs) and Independent Ethics Committees (IECs).
Serve as EDC administrator, supporting site monitoring activities through EDC and eDTM/EDX applications.
Conduct ongoing risk assessments throughout the project lifecycle, including site process evaluations, follow-up on outstanding items, and timely escalation of issues.
Collaborate cross-functionally with internal departments — including Drug Safety, Regulatory, Data Management, and Biostatistics — to ensure seamless study execution.