Lead Clinical Trial Associate

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.
• Affiliate 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.