Sub Investigator Jobs

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.

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.

Summary

• Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study
• Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity’s SOPs
• Serve as leader of a study team to execute clinical trials
• Develop Quality Control strategies for team member projects
• Create training strategies and mitigation plans
• Ensure staff are delegated and trained appropriately and documented
• Ensure confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information is maintained by all team members
• 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.
• Create and execute recruitment strategies in conjunction with patient recruitment staff
• 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.
• Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner
• Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol.
• Other duties as assigned
• Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.
• Perform clinical duties (e.g. Drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope
• Understand the disease process or condition under study
• Ensure the creation, collection and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.
• 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.
• Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol
• Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills
• 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 good documentation practices are applied by team members when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries
• Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
• Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.
• Promote respect for cultural diversity and conventions with all individuals.

Required Skills/Abilities

• Practices professionalism and integrity in all actions – Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done
• Safe handling of data and records regarding privacy and confidentiality, per HIPAA requirements.
• Other duties as assigned.
• Must be licensed as a MD, DO, NP, or PA in the state you work in.
• 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 as needed.
• Must undertake all training and certification required by sponsors and CRO’s to carry out clinical trials within specified timelines.

Education and Experience

• Must be a licensed MD, DO, NP, or PA.
• 5+ years of clinical management experience or equivalent applicable experience in clinical research industry

Physical Requirements

• Must be able to lift up to 15 pounds at times.
• Must undertake all training and certification required by sponsors and CRO’s to carry out clinical trials within specified timelines.
• Other duties as assigned.
• Prolonged periods of sitting at a desk and working on a computer.
• Safe handling of data and records regarding privacy and confidentiality, per HIPAA requirements.
• Up to 10% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.
• Must be licensed as a MD, DO, NP, or PA in the state you work in.
• 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).

Education and Experience

• Must be a licensed MD, DO, NP, or PA.
• 5+ years of clinical management experience or equivalent applicable experience in 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.