Job Title: Clinical Research Coordinator III

Job Description

The Clinical Research Coordinator III plays a pivotal role as an experienced clinical research professional, providing leadership in planning, implementing, monitoring, and evaluating multiple clinical research protocols. This position involves managing the daily operations of various studies, from protocol development and initiation to study close-out, in accordance with regulatory and sponsor guidelines. The role ensures the integrity of each study and mentors less experienced Clinical Research Coordinators. The incumbent will work closely with study team members and other staff to ensure participant safety and adherence to approved protocols, while managing administrative tasks and orchestrating study activities.

Responsibilities

• Coordinate the implementation of multiple complex clinical research protocols.
• Develop Standard Operating Procedures (SOPs) and templates with guidance from the Principal Investigator or Clinical Research Manager.
• Oversee eligibility screening and study recruitment activities, implementing strategies to increase accrual.
• Manage sample processing, packing, and shipping according to protocol and regulations.
• Plan and operationalize strategies to monitor, document, and report unanticipated occurrences and protocol deviations.
• Develop and implement preventive and corrective actions.
• Disseminate and ensure adherence to study-related clinical research best practices and scientific manuals.
• Lead protocol implementation and study progress, keeping investigators informed.
• Identify and address ethical conflicts during protocol implementation, consulting with the Research Ethics Team as needed.
• Organize and manage site visits and internal/external auditing activities.
• Coordinate research team meetings and ensure effective communication across the board.
• Ensure synchronization of study visits, procedures, and clinical tests with data collection schedules.
• Compile information needed for research reports and peer-reviewed publications, and develop strategies to disseminate information to clinical personnel and stakeholders.
• Follow the requirements of all international, national, and local regulatory bodies.
• Maintain requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies.
• Adhere to policies and procedures, safeguarding organizational assets.

Essential Skills

• Research analysis
• Patient Consent
• ICF Review
• Patient Management experience
• Patient records
• Institutional Review Board (IRB) knowledge
• Clinical trials
• Oncology
• Clinical research
• Electronic Data Capture (EDC)

Additional Skills & Qualifications

• Bachelor's degree required
• At least 2 years of solid Clinical Research Coordinator (CRC) skills in managing and running trials
• Oncology experience preferred, but candidates with Cardio, HIV, or Infectious Disease experience will also be considered
• ACRP/SOCRA certification or willingness to obtain within 6 months of employment - oncology experience is a must

Work Environment

This position is primarily in-office, with work hours from Monday to Friday, 8 am to 5 pm. There is flexibility for 1-2 days of remote work per week if not seeing patients.

Job Type & Location

This is a Contract to Hire position based out of MIAMI, Florida.