Senior Clinical Research Associate (CNS)
Description
Senior CRA - Miami Area
C-Clinical is hiring a Senior Clinical Research Associate (CRA) with experience in CNS, oncology, or metabolic indications to join our growing team in the Miami area. This is a hybrid role that combines remote, risk-based monitoring with on-site visits as needed.
We're seeking experienced professionals who are passionate about advancing clinical research and ready to make a meaningful impact. The ideal candidate is proactive, detail-oriented, and brings a strong understanding of regulatory requirements, site engagement, and protocol compliance.
At C-Clinical, we're committed to life-changing work-and we want to grow with individuals who share that same drive. Our team values collaboration, integrity, and purpose in every study we support.
If you're a skilled CRA based in or around Miami and ready to contribute to a mission-driven research team, we'd love to connect.
Apply today and please complete the brief intro survey sent via email after submission.
Responsibilities
Sr. CRA - Miami Area (On-site/Hybrid)
• Interfaces with the study team to ensure timely initiation and completion of clinical trials
• Responsible for the identification, evaluation, and qualification of investigators and sites in the Miami area and surrounding region
• May prepare and submit essential document packages required for clinical site initiation
• Performs on-site monitoring activities for clinical trials and escalates site issues to the Clinical Trial Manager (CTM)/Project Manager (PM); documents activities in the monitoring reports and follow-up correspondence
• Reviews and manages data on-site and remotely; resolves issues on a continuous basis to achieve timely database targets
• May be responsible for all aspects of study site monitoring: pre-study visits, site initiation visits, routine monitoring visits, close-out visits of clinical sites, and maintenance of study files, with or without guidance
• Ensures the protection of research subjects by verifying that informed consent procedures and protocol requirements are followed in accordance with applicable regulatory requirements
• Identifies, tracks, and follows up on all Adverse Events (AEs) and Serious Adverse Events (SAEs); ensures all applicable SAEs are reported to appropriate regulatory authorities
• Ensures the accuracy and integrity of data submitted on electronic or paper case report forms (CRFs), or other data collection tools, through comprehensive source document review; monitors study databases for missing or discrepant data compared to source records
• Ensures that all monitoring tasks are performed according to site SOPs, established guidelines, work instructions, and project-specific plans (e.g., monitoring plan)
• Maintains study blinding and serves as a blinded study monitor as needed; conducts eCRF/CRF review, query generation, and resolution in line with established data review guidelines
• Attends investigator meetings, project team meetings, and teleconferences as required
• Understands and applies knowledge of local, state, and federal regulations (e.g., FDA, ICH-GCP)
• Maintains current training on ICH-GCP, study protocols, and internal procedures
• May track regulatory documentation, monitor recruitment progress, evaluate site quality and compliance, and help motivate assigned sites to meet deadlines and performance expectations
Qualifications
• 3 years or more as a CRA with site monitoring responsibility And 1 year or more CNS
Or
• 3 years or more as a CRA with site monitoring responsibility And 1 year or more in either: Phase 1, a complex indication with in-patient monitoring, Or metabolic studies
Or
• 3 years or more as a CRA with site monitoring responsibility And 1 year or more in Oncology Monitoring
And
• The candidate possesses a 4-year university degree, ideally in a scientific field
• In lieu of a 4-year university degree, a candidate with 7 or more years of relevant clinical research experience, nursing/possibly another medical certification, and 5 years of monitoring in a complex indication (in-patient, oncology, phase 1, etc.) may be considered
• Must have working rights in the United States
• Must be located within the greater Miami area
• The candidate must have availability for at least 1 year
• Must possess exemplary verbal skills in the English language with the ability to solve complex problems using medical terminology
• Bi-lingual is a plus
• Corp to Corp
• Must be proficient at tactfully managing intra-team communication, as well as interpersonal communication
• Note: the travel rate is 50% regular rate