Trial Master File Jobs in Florida (NOW HIRING)

Salary: $70,000-80,000 Salary

Sitero is a next-generation, technology-enabled Clinical Research Organization (CRO) serving the life sciences industry. We combine deep expertise across a diverse range of therapeutic areas with an innovative, tech-forward approach to clinical research helping sponsors and sites get treatments to patients safer and faster. From early phase studies through Phase III clinical trials, our team delivers high-touch services and purpose-built technology with an unwavering commitment to ethics, compliance, and patient safety. With offices in the US, UK, Canada, and India, Sitero operates globally to support the full clinical program lifecycle.

Title: Lead Clinical Trial Associate

Location: 3 days per week in our Coral Gables, Florida office. 2 days per week from home

Function: Clinical Operations

Employment Type: Full Time

The Lead Clinical Trial Associate (Lead 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.

Essential Duties & 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.

Education & Experience

• Bachelor's or Master's degree in Life Sciences, Nursing, Pharmacy, or a related field from an accredited university.
• Minimum 5 years 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.

Preferred Skills

• 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.

Commitments

• Drivable distance to our Headquarter office in Coral Gables, Florida.
• Standard schedule: 40 hours per week, Monday through Friday, with a one-hour lunch break.
• Flexibility to work adjusted hours or shifts as study timelines and global team collaboration require.

Compensation & Benefits

Sitero offers a competitive compensation and benefits package including base salary, paid time off, and comprehensive healthcare and retirement benefits. Specific details will be discussed during the recruitment process.

Equal Opportunity Employer

Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.