Velocity Clinical Research, Inc.
Velocity Clinical Research is an owned and integrated research site organization that delivers excellence in patient care, high‑quality data, and fully integrated research sites. The company is committed to making clinical trials succeed by generating high‑quality data from as many patients as possible, quickly, while providing exemplary patient care at every step.
Summary
The Sub Investigator is responsible for the clinical safety of patients participating in the clinical trial, collecting and recording accurate clinical data, and ensuring the well‑being and interests of study subjects are protected. The Sub‑I provides essential clinical support to clinical research coordinators, principal investigators, and other clinical‑trial staff. Responsibilities
Serve as leader of a study team to execute clinical trials. Mentor and train staff in 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 timely data entry, 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. Maintain confidentiality of patient protected health information, sponsor confidential information, and Velocity confidential information. Develop communication and escalation strategies within teams to ensure patient safety is upheld and all adverse events are reported in accordance with protocol and Velocity SOPs. Ensure all data is entered into the sponsor’s data portal and all queries are resolved in a timely manner. Delegate and train staff appropriately and document their training. Create 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 prescreens. Create and execute recruitment strategies in conjunction with patient recruitment staff. Incorporate key timelines, endpoints, required vendors, and patient population when planning each assigned protocol. Understand how decisions affect the bottom line and link operations to the company’s financial performance. Understand the product development lifecycle and the significance of protocol design, including critical data points. Develop quality‑control strategies for team member projects. Perform clinical duties such as drug preparation and administration, fibroscan, phlebotomy, ECG, and 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. Qualifications
Must be licensed as an MD, DO, NP, or PA in the state of employment. Must complete all training and certification required by sponsors and CROs within specified timelines. Safe handling of data and records regarding privacy and confidentiality, per HIPAA requirements. Demonstrated ability to practice professionalism and integrity, 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 professional conferences. Education and Experience
Must be licensed MD, DO, NP, or PA. 5+ years of clinical management experience or equivalent applicable experience in the clinical research industry. 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. 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, 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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The Sub Investigator is responsible for the clinical safety of patients participating in the clinical trial, collecting and recording accurate clinical data, and ensuring the well‑being and interests of study subjects are protected. The Sub‑I provides essential clinical support to clinical research coordinators, principal investigators, and other clinical‑trial staff. Responsibilities
Serve as leader of a study team to execute clinical trials. Mentor and train staff in 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 timely data entry, 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. Maintain confidentiality of patient protected health information, sponsor confidential information, and Velocity confidential information. Develop communication and escalation strategies within teams to ensure patient safety is upheld and all adverse events are reported in accordance with protocol and Velocity SOPs. Ensure all data is entered into the sponsor’s data portal and all queries are resolved in a timely manner. Delegate and train staff appropriately and document their training. Create 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 prescreens. Create and execute recruitment strategies in conjunction with patient recruitment staff. Incorporate key timelines, endpoints, required vendors, and patient population when planning each assigned protocol. Understand how decisions affect the bottom line and link operations to the company’s financial performance. Understand the product development lifecycle and the significance of protocol design, including critical data points. Develop quality‑control strategies for team member projects. Perform clinical duties such as drug preparation and administration, fibroscan, phlebotomy, ECG, and 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. Qualifications
Must be licensed as an MD, DO, NP, or PA in the state of employment. Must complete all training and certification required by sponsors and CROs within specified timelines. Safe handling of data and records regarding privacy and confidentiality, per HIPAA requirements. Demonstrated ability to practice professionalism and integrity, 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 professional conferences. Education and Experience
Must be licensed MD, DO, NP, or PA. 5+ years of clinical management experience or equivalent applicable experience in the clinical research industry. 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. 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, 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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