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 study subjects. This role 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 document review, scheduling subjects, protocol training, collection of regulatory documents, conducting visits, ensuring timely data entry and query resolution, managing and reporting adverse events, serious adverse events, and deviations, implementing protocol amendments, and providing close-out reports.
• Apply project management concepts to manage risk and improve quality in clinical research studies.
• 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 followed by team members when collecting and correcting data, transferring data to sponsor/CRO systems, and resolving queries.
• Maintain confidentiality of patient protected health information, sponsor confidential information, and Velocity confidential information.
• Develop communication and escalation strategies to uphold patient safety and ensure adverse events, serious adverse events, and adverse events of special interest are reported in accordance with protocol and SOPs.
• Ensure all data is entered into the sponsor’s data portal and queries are resolved in a timely manner.
• Ensure staff are delegated and trained appropriately and documented.
• Create, collect, and submit 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.
• Understand how decisions affect the bottom line, including links between operations and financial performance, to create value for all stakeholders.
• Understand the product development lifecycle and significance of protocol design, including 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.

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.
• Demonstrated ability to foster teamwork, cooperation, self-control, and flexibility.
• 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.

Skills

• Practices professionalism and integrity in all actions.
• Leadership and mentoring of clinical research teams.
• Project management and risk assessment.
• Clinical trial execution and regulatory compliance.
• Patient recruitment and evaluation.
• Understanding of financial and operational impacts on clinical trials.

Benefits

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

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.