Sub Investigator

Skills

Requirements

Benefits

About the role

containing company overview and summary. Company overview: first paragraph up to "Benefits include ..."? Actually benefits are listed there; but we will move benefits to its own section. So we should exclude benefits from About the role paragraph. So we need to split: The first paragraph includes benefits sentence at end. We'll extract benefits separately. So About the role paragraph: everything before "Benefits include". Let's capture: "Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity." Then after that, we have "Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program." We'll put that in Benefits section. Then Summary paragraph: "The Sub Investigator has responsibility for the clinical safety of the patients partaking in the clinical trial, collecting, and recording accurate clinical data while also ensuring that the well-being and interests of the subjects enrolled in the studies are being met. The Sub-I provides essential clinical support to the clinical research coordinators, principal investigators, and other clinical trials staff." We can include that in About the role paragraph after company overview, or as separate

. Probably combine. Thus About the role: two paragraphs: company overview and summary. Now Responsibilities: we need to extract list items from the long responsibilities paragraph. Let's copy the responsibilities text: "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 and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, 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 that 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 prescreens. 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 company’s financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol. Incorporate understanding of 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" We need to split into sensible list items. Each sentence seems separated by a period. We'll split by period and trim. Let's list: 1. Serve as leader of a study team to execute clinical trials 2. Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills 3. Create training strategies and mitigation plans 4. Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity’s SOPs 5. 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 and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports. 6. Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study 7. Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols. 8. Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors. 9. 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 10. Ensure confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information is maintained by all team members 11. Develop communication and escalation strategies within teams to that 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 12. Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner 13. Ensure staff are delegated and trained appropriately and documented 14. Ensure the creation, collection and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements. 15. Evaluate potential subjects for participation in clinical trials including phone and in person pre‑screens. 16. Create and execute recruitment strategies in conjunction with patient recruitment staff 17. Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol. 18. Incorporate understanding of how decisions affect the bottom-line including links between operations and company’s financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol. 19. Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol 20. Develop Quality Control strategies for team member projects 21. Perform clinical duties (e.g. Drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope 22. Prom