Clinical Operations Manager – Traveling CRC Team

This is a fully remote position, open to applicants in Florida.

📋 Description

• Coordinate and implement clinical research support across various site locations.

• Manage and assist a high-performing traveling team to improve efficiencies, ensure patient safety, maintain protocol/GCP/regulatory compliance, and achieve targets.

• Collaborate with leaders in Study Delivery, Operations, Strategy, and Training to align on delivery expectations, milestones, and quality data for sponsors.

• Oversee resource allocations, site assignments, team performance, study deliverables, risks, timelines, quality, and budget management.

• Support site performance objectives, identify and address issues, and guarantee data quality.

• Assist in training staff on clinical systems, protocols, CRF completion, SOPs, GCP, IATA, clinical plans, and guidelines.

• Supervise assigned site personnel, including performance, compliance, timecards, pay, absences, orientation, and training.

• Conduct patient screenings, obtain consent, perform follow-up visits, manage source documentation, EDC data entry and query responses, vital signs, ECGs, and basic laboratory procedures as required by protocol.

• Request and monitor medical records; maintain logs, charts, supplies, and source documents.

• Schedule study visits, conduct appointment reminders, monitoring visits, and ensure timely issue resolution.

• Ensure investigator review of study reports and patient results; file SAE/deviation reports; document adverse events and report instances of non-compliance.

• Complete study start-up tasks and required training and documentation.

• Ensure compliance with SOPs, GCP, FDA regulations, company policies, and procedures.

• Collaborate with investigators, site teams, and support teams to achieve goals and meet timelines.

• Propose and implement risk mitigation strategies; participate in and present at management, production, and site meetings.

• Travel up to 100% as necessary.

⛳️ Requirements

• An associate’s degree and a minimum of 3 years of clinical research experience, or an equivalent combination of education and experience, is required.

• A minimum of 1 year of management experience is required.

• Proficiency in Microsoft applications, email, electronic health records, web applications, and typing at 40+ wpm.

• Strong project management and organizational capabilities.

• Ability to manage multiple priorities and adhere to timelines.

• Exceptional communication and stakeholder management skills.

• Strong problem-solving abilities and risk mitigation skills.

• Highly organized with a keen attention to detail.

• Well-developed written and verbal communication abilities.

• Professional, respectful, self-motivated, with a strong work ethic.

• High level of integrity and dependability.

• Ability to work with minimal supervision, recognize problems, and implement solutions.

• Capability to handle highly sensitive information confidentially and professionally in accordance with HIPAA guidelines.

• Up to 50% travel as necessary.

• Bilingual proficiency in English and Spanish is a plus.

🏝️ Benefits

• Full-time employees scheduled to work at least 30 hours per week are eligible for benefits, with coverage commencing on the first day of the month following the date of hire.

• Offered benefits include medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match.