Sub Investigator

Join to apply for the Sub Investigator role at Velocity Clinical Research, Inc.

Velocity Clinical Research is an integrated research site organization committed to delivering high-quality clinical data while providing exemplary patient care. At Velocity, we invest in career advancement and reward performance.

Benefits include medical, dental and vision insurance, paid time off, company holidays, 401(k) with company match, and an annual incentive program.

Summary

The Sub Investigator is responsible for the clinical safety of patients participating in clinical trials, collecting accurate clinical data while ensuring patient well-being and interests are met.

Duties / Responsibilities

• Lead a study team to execute clinical trials.
• Mentor and train staff on protocol requirements and trial management skills.
• Create training strategies and mitigation plans.
• Conduct and manage trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity's SOPs.
• Implement and coordinate assigned trials including start-up, vendor management, subject recruitment, source development review, scheduling, protocol training, collection of regulatory documents, conducting visits, data entry, query resolution, adverse event management, protocol amendment implementation, and close-out reports.
• Apply project management concepts to manage risk and improve quality in study conduct.
• Develop, coordinate, and implement research and administrative strategies to manage assigned protocols.
• Communicate effectively with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
• Ensure good documentation practices are applied by team members.
• Ensure confidentiality of protected health information and confidential information is maintained by all team members.
• Develop communication and escalation strategies to ensure patient safety and report adverse events per protocol and Velocity SOPs.
• Ensure all data is entered into the sponsor's data portal and all queries are resolved promptly.
• Ensure staff are delegated and trained appropriately and documented.
• Ensure creation, collection and submission of regulatory documents to sponsors and IRBs as required.
• Evaluate potential subjects for participation in clinical trials including phone and in-person prescreens.
• Create and execute recruitment strategies with patient recruitment staff.
• Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol.
• Incorporate understanding of how decisions affect bottom-line and create value for stakeholders.
• Incorporate understanding of product development lifecycle and protocol design critical data points.
• Develop quality control strategies for team member projects.
• Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope.
• Promote respect for cultural diversity and conventions with all individuals.
• Understand the disease process or condition under study.
• Other duties as assigned.

Required Skills / Abilities

Education and Experience

Physical Requirements

NOTE

The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and / or as requested by management.

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