Qureos Mentor

Velocity Clinical Research, Inc.

Velocity Clinical Research is a leading clinical trial site organization that partners with pharmaceutical and biotechnology companies to conduct research on new drugs, medical devices, and diagnostics aimed at improving human health. With a focus on delivering high-quality clinical trial data and patient care, Velocity operates integrated research sites across the U.S. and Europe, ensuring efficient enrollment and performance for clinical trials.

<div><div>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.</div><div></div><div><br>
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.</div><div></div><div><br>
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.</div><div></div><div><b><br>
Summary:</b></div><div>
The Clinical Research Coodinator I conducts and manages clinical trials in accordance with the study protocol,GCP, and Velocity&rsquo;s SOPs.</div><div><b><br>
Duties/Responsibilities:</b></div><ul><li>
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity&rsquo;s SOPs</li><li>
Coordinate, with supervision, 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.</li><li>
Implement research and administrative strategies to successfully manage assigned protocols.</li><li>
Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.</li><li>
Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems, and resolving queries</li><li>
Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information</li><li>
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.</li><li>
Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner</li><li>
Ensure staff are delegated and trained appropriately and documented</li><li>
Create, collect, and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.</li><li>
Evaluate potential subjects for participation in clinical trials including phone and in person pre screens.</li><li>
Execute recruitment strategies defined by Clinical Research Team</li><li>
Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol.</li><li>
Perform clinical duties (e.g. drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope</li><li>
Promote respect for cultural diversity and conventions with all individuals.</li></ul><div><b><br>
Education/Experience:</b></div><ul><li>
Bachelor&rsquo;s degree with 1 year of relevant experience in the life science industry OR</li><li>
Associate&rsquo;s degree with 2 years of relevant experience in the life science industry OR</li><li>
High School Graduate and/or technical degre with minimum of 3 years relevant experience in the
<br>
life science industry</li></ul><div><b>
Required Licenses/Certifications:</b></div><ul><li>
Phlebotomy if applicable and required by state law</li><li>
Intramuscular dose administration and preparation if applicable and required by state law</li></ul><div><b>
Required Skills:</b></div><ul><li>
Demonstrated knowledge of medical terminology</li><li>
Demonstrated ability in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.</li><li>
Demonstrated bility to work in a fast-paced environment</li><li>
Demonstrated verbal, written, and organizational skills</li><li>
Demonstrated interpersonal and communication skills</li><li>
Demonstrated ability to work as a team player</li><li>
Demonstrated ability to read, write, and speak English</li><li>
Demonstrated ability to multi-task</li><li>
Demonstrated ability to follow written guidelines</li><li>
Demonstrated ability to work independently, plan and prioritize with some guidance</li><li>
Demonstrated ability to be flexible/adapt as daily schedule may change rapidly</li><li>
Must be detail oriented</li><li>
Demonstrated problem solving and strategic decision making ability.</li><li>
Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised.</li></ul><div><b>
Required Physical Abilites:</b></div><ul><li>
Sit or stand for long periods of time</li><li>
Travel locally and nationally</li><li>
Communicate in person and by a telephone</li><li>
Limited walking required</li><li>
Limited to lifting up to 30 pounds</li></ul><div>
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, the 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.</div></div>

Clinical Research Coordinator I

<div><div>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.</div><div></div><div><br>
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.</div><div></div><div><br>
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.</div><div></div><div><b><br>
Summary:</b></div><div>
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.</div><div><b><br>
Duties/Responsibilities</b></div><ul><li>
Serve as leader of a study team to execute clinical trials</li><li>
Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills</li><li>
Create training strategies and mitigation plans</li><li>
Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity&rsquo;s SOPs</li><li>
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.</li><li>
Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study</li><li>
Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols.</li><li>
Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.</li><li>
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</li><li>
Ensure confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information is maintained by all team members</li><li>
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</li><li>
Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner</li><li>
Ensure staff are delegated and trained appropriately and documented</li><li>
Ensure the creation, collection and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements.</li><li>
Evaluate potential subjects for participation in clinical trials including phone and in person pre screens.</li><li>
Create and execute recruitment strategies in conjunction with patient recruitment staff</li><li>
Incorporate key timelines, endpoints, required vendors, and patient population when planning for each assigned protocol.</li><li>
Incorporate understanding of how decisions affect the bottom-line including links between operations and company&rsquo;s financial performance and how it is essential to create value of all stakeholders of the organization when planning for each assigned protocol.</li><li>
Incorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocol</li><li>
Develop Quality Control strategies for team member projects</li><li>
Perform clinical duties (e.g. Drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scope</li><li>
Promote respect for cultural diversity and conventions with all individuals.</li><li>
Understand the disease process or condition under study</li><li>
Other duties as assigned</li></ul><div><b><br>
Required Skills/Abilities:</b></div><ul><li>
Must undertake all training and certification required by sponsors and CRO&rsquo;s to carry out clinical trials within specified timelines.</li><li>
Safe handling of data and records regarding privacy and confidentiality, per HIPAA
<br>
requirements.</li><li>
Practices professionalism and integrity in all actions &ndash; Demonstrated ability to foster
<br>
concepts of teamwork, cooperation, self- control, and flexibility to get the work done</li><li>
Ability to communicate effectively in English (both verbal and written).</li><li>
Up to 10% travel, as needed, for project team meetings, client presentations and other
<br>
professional meetings/conferences as needed.</li><li>
Other duties as assigned.</li></ul><div><b>
Education and Experience:</b></div><ul><li>
Must be a licensed MD, DO, NP, or PA.</li><li>
5+ years of clinical management experience or equivalent applicable experience in clinicalresearch industry</li></ul><div><b>
Physical Requirements:</b></div><ul><li>
Prolonged periods of sitting at a desk and working on a computer.</li><li>
Must be able to lift up to 15 pounds at times.</li></ul><div><b>
NOTE:</b> 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, the 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.</div></div>

Sub Investigator

Join Velocity Clinical Research, Inc. and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Velocity Clinical Research, Inc.

About Company

Clinical Research Coordinator I

Sub Investigator

Clinical Research Coordinator I