Senior Clinical Research Coordinator

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

• Subject matter expert and leader of a clinical trial team to conduct and manage clinical trial(s) from start up through study close out in accordance with the study protocol, GCP, and Velocity’s SOPs.

Role & Responsibilities

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

Education/Experience

• High School Graduate and/or technical degree and 8 years as a Clinical Research Coordinator
• Bachelor’s degree and 4 years as a Clinical Research Coordinator OR
• Associate’s degree and 6 years as a Clinical Research Coordinator OR

Required Licenses/Certifications

• Phlebotomy if applicable and required by state law Intravenous/Intramuscular dose administration and preparation if applicable and required by state law Certified Clinical Research Coordinator through ACRP or SOCRA within six months of being in the role

Required Skills

• Advanced in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.
• Advanced interpersonal and communication skills
• Proficient in the use of the following technology Computers, Microsoft Office software, fax, copier, and multi-line telephone.
• Must be detail oriented
• Advanced ability to read, write, and speak English
• Proficient leader, mentor and team builder
• Advanced knowledge of medical terminology
• Demonstrated ability to be flexible/adapt as daily schedule may change rapidly
• Advanced ability to work as a team player
• Demonstrated ability to work independently, plan and prioritize multiple deliverables and objectives
• Proficient problem solving and strategic decision making ability.
• Demonstrated ability to multi-task
• Profcient ability to work in a fast-paced environment
• Advanced verbal, written, and organizational skills
• Advanced ability to follow written guidelines

Required Physical Abilites

• Travel locally and nationally
• Limited walking required
• Communicate in person and by a telephone
• Limited to lifting up to 30 pounds
• Sit or stand for long periods of time

Velocity is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. We are an E-Verify Employer in the United States.