Clinical Research Coordinator

Clinical Research CoordinatorEximia Clinical Research is looking for a Clinical Research Coordinator to join our team. As the Clinical Research Coordinator, you will act as the subject matter expert and manage clinical trial(s) from start up through study close out in accordance with the study protocol, GCP, and Eximia Clinical Research’s SOPs.Role & Responsibilities:Serve as lead of studies to execute clinical trialsTrain staff in the conduct of clinical trials, protocol requirements, communication,and trial management skillsConduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelinesand Eximia Clinical Research’s SOPsPerform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulationsProcess, package and ship laboratory specimens as required per protocol and IATA regulations, if applicableImplement and coordinate assigned clinical trials including start up, vendor management,subject recruitment, source development review, scheduling subjects, protocol training,collection of regulatory documents, participating in the ICF process(es), 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 aclinical research studyDevelop, coordinate, and implement research and administrative strategies to successfullymanage assigned protocols.Communicate effectively and professionally with coworkers, leadership, study subjects,sponsors, CROs, and vendors.Ensure good documentation in accordance with ALCOA-C principles 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 informationand Eximia Clinical Research confidential information is maintained by all team membersDevelop communication and escalation strategies within teams to that ensure patient safety isupheld and all adverse events, serious adverse events, and adverse events of special interestare followed and reported in accordance with the protocol and Eximia Clinical Research SOPsDevelop or contribute to development of tools and training to prepare for and/or participate in site audits and inspectionsEnsure all data is entered into the sponsor's data portal and all queries are resolved in a timelymanner as set forth in the Clinical Trial AgreementEnsure the creation, collection and submission of regulatory documents to Sponsors and IRBsas required per protocol, GCP/ICH regulations and IRB requirements.Evaluate potential subjects for participation in clinical trials including phone and in person prescreens.Incorporate key timelines, endpoints, required vendors, and patient population when planningfor each assigned protocol.Incorporate understanding of how decisions affect the bottom-line including links betweenoperations and company’s financial performance and how it is essential to create value of allstakeholders of the organization when planning for each assigned protocol.Incorporate understanding of product development lifecycle and significance of protocoldesign 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 6 years as a Clinical Research Coordinator ORAssociate’s degree and 8 years as a Clinical Research Coordinator ORHigh School Graduate and/or technical degree and 10 years as a Clinical Research CoordinatorRequired Licenses/Certifications:Phlebotomy if applicable and required by state lawIntravenous/Intramuscular dose administration and preparation if applicable and required by state lawCertified Clinical Research Coordinator through ACRP or SOCRA within six months of being in the role

Required Skills

Advanced knowledge of medical terminologyProficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone.Proficient 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 Abilities:Sit or stand for long periods of timeCommunicate in person and by telephoneLimited to moderate walkingLimited lifting up to 30 poundJob Type: Full-time

Benefits

401(k)401(k) matchingDental insuranceEmployee assistance programFlexible spending accountHealth insuranceHealth savings accountLife insurancePaid time offVision insuranceWork Location: In person