Senior Clinical Research Coordinator

Clinical Trial LeaderVelocity 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.ResponsibilitiesServe as leader of a study team to execute clinical trialsMentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skillsCreate training strategies and mitigation plansConduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity's SOPsImplement 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 studyDevelop, 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 queriesEnsure confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information is maintained by all team membersDevelop 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 SOPsEnsure all data is entered into the sponsor's data portal and all queries are resolved in a timely mannerEnsure staff are delegated and trained appropriately and documentedEnsure 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 staffIncorporate 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 protocolIncorporate understanding of product development lifecycle and significance of protocol design including critical data points when planning for each assigned protocolDevelop Quality Control strategies for team member projectsPerform clinical duties (e.g. Drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scopePromote respect for cultural diversity and conventions with all individuals.Understand the disease process or condition under studyOther duties as assignedQualificationsEducation/Experience:Bachelor's degree and 4 years as a Clinical Research Coordinator ORAssociate's degree and 6 years as a Clinical Research Coordinator ORHigh School Graduate and/or technical degree and 8 years as a Clinical Research CoordinatorRequired 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 roleRequired Skills:Advanced knowledge of medical terminologyProficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.Profcient ability to work in a fast-paced environmentAdvanced verbal, written, and organizational skillsAdvanced interpersonal and communication skillsAdvanced ability to work as a team playerAdvanced ability to read, write, and speak EnglishDemonstrated ability to multi-taskAdvanced ability to follow written guidelinesDemonstrated ability to work independently, plan and prioritize multiple deliverables and objectivesDemonstrated ability to be flexible/adapt as daily schedule may change rapidlyMust be detail orientedProficient problem solving and strategic decision making ability.Advanced in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised.Proficient leader, mentor and team builderRequired Physical Abilites:Sit or stand for long periods of timeTravel locally and nationallyCommunicate in person and by a telephoneLimited walking requiredLimited to lifting up to 30 poundsNOTE: 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.