Sub Investigator

About the role

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high-quality data, and fully integrated research sites. The Sub Investigator is responsible for the clinical safety of patients participating in clinical trials, collecting and recording accurate clinical data, and ensuring the well-being and interests of enrolled subjects. The Sub-I provides essential clinical support to clinical research coordinators, principal investigators, and other clinical trials staff.

Responsibilities

• Serve as leader of a study team to execute clinical trials.
• Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills.
• Create training strategies and mitigation plans.
• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity’s SOPs.
• Implement and coordinate assigned clinical trials including start-up, vendor management, subject recruitment, source development review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner, resolving queries, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, and providing all close-out reports.
• Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study.
• Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
• Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
• Ensure good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems, and resolving queries.
• Ensure confidentiality of patient protected health information, sponsor confidential information, and Velocity confidential information is maintained by all team members.
• Develop communication and escalation strategies within teams to ensure patient safety is upheld and all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and Velocity SOPs.
• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner.
• Ensure staff are delegated and trained appropriately and documented.
• Ensure the creation, collection, and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.
• Evaluate potential subjects for participation in clinical trials including phone and in-person pre-screens.
• Create and execute recruitment strategies in conjunction 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 the bottom-line, including links between operations and the company’s financial performance, and how it is essential to create value for all stakeholders of the organization when planning for each assigned protocol.
• Incorporate understanding of the product development lifecycle and significance of protocol design, including critical data points when planning for each assigned protocol.
• 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.

Requirements

• Must be a licensed MD, DO, NP, or PA.
• 5+ years of clinical management experience or equivalent applicable experience in the clinical research industry.
• Must undertake all training and certification required by sponsors and CROs to carry out clinical trials within specified timelines.
• Safe handling of data and records regarding privacy and confidentiality, per HIPAA requirements.
• Practices professionalism and integrity in all actions.
• Demonstrated ability to foster concepts of teamwork, cooperation, self-control, and flexibility to get the work done.
• Ability to communicate effectively in English (both verbal and written).
• Up to 10% travel, as needed, for project team meetings, client presentations, and other professional meetings/conferences.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at times.

Benefits

• Medical, dental, and vision insurance.
• Paid time off and company holidays.
• 401(k) retirement plan with company-match.
• Annual incentive program.