Clinical Research Coordinator I

Clinical Research Coordinator IThe Clinical Research Coordinator I conducts and manages clinical trials in accordance with the study protocol, GCP, and Velocity's SOPs.Duties/Responsibilities:Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and Velocity's SOPsCoordinate, 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.Implement research and administrative strategies to successfully manage assigned protocols.Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems, and resolving queriesMaintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential informationEnsure 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 mannerEnsure staff are delegated and trained appropriately and documentedCreate, collect, and submit 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.Execute recruitment strategies defined by Clinical Research TeamUnderstand key timelines, endpoints, required vendors, and patient population for each assigned protocol.Perform clinical duties (e.g. drug preparation and administration, fibroscan, phlebotomy, ECG, lab processing) within scopePromote respect for cultural diversity and conventions with all individuals.Education/Experience:Bachelor's degree with 1 year of relevant experience in the life science industry ORAssociate's degree with 2 years of relevant experience in the life science industry ORHigh School Graduate and/or technical degree with minimum of 3 years relevant experience in the life science industryRequired Licenses/Certifications:Phlebotomy if applicable and required by state lawIntramuscular dose administration and preparation if applicable and required by state lawRequired Skills:Demonstrated knowledge of medical terminologyDemonstrated ability in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.Demonstrated ability to work in a fast-paced environmentDemonstrated verbal, written, and organizational skillsDemonstrated interpersonal and communication skillsDemonstrated ability to work as a team playerDemonstrated ability to read, write, and speak EnglishDemonstrated ability to multi-taskDemonstrated ability to follow written guidelinesDemonstrated ability to work independently, plan and prioritize with some guidanceDemonstrated ability to be flexible/adapt as daily schedule may change rapidlyMust be detail orientedDemonstrated problem solving and strategic decision making ability.Proficient ability to accept individual responsibility for actions taken and demonstrate professionalism when judged, critiqued and/or praised.Required Physical Abilities: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.