Clinical Research Coordinator

Summary : The Clinical Research Coordinator reports to the Manager of Clinical Research and will aid in the coordination and conduct of research under the supervision of a designated physician. The Clinical Research Coordinator will perform a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. The Clinical Research Coordinator has knowledge of the research studies, rationale, subjects and procedures associated with the studies.Role and Responsibilities : Leads recruitment efforts and screens potential patients for eligibility for studies.Obtains informed consent from patients and conducts study visits for clinical trialsCreates Case Report FormsCompletes assessments on study subjects as per protocolDocuments study assessmentsEnters study data into EDC systemsCollects, processes, stores and ships lab specimens; documents lab procedures, lab results and follows up with patients and medical staff as necessaryCoordinates, monitors visits with CRAs for each trial to ensure accurate documentation; makes corrections to data as necessaryAssists during Sponsor and FDA auditsResponsible for submissions and reports to the IRB; maintains documentation of IRB communications and decisionsDocuments adverse events and notifies PI, sponsor and IRBAssumes test article accountabilityPossesses a sound and in-depth understanding of each protocol that has been assigned as a primary responsibilityMaintains compliance with Good Clinical Practice; Clinical Safety Data Management, 21 CFR, and has IATA certificationTravels to investigator meetingsParticipates in weekly meetings with the research team, provides study metricsResponds to requests in a timely manner, gives / receives correct information, encourages dialogue and follow-through, secures accurate signatures, maintains files in an organized and up-to-date mannerEssential Qualifications : Education : Bachelor's degree preferably in Science or related field. Equivalent relevant experience and / or training in lieu of education is acceptable. Experience : 2 years' relevant experience (e.g. research, clinical, interaction with study population, program coordination)Knowledge / Skills / Other Abilities : Excellent Excel, Word, PowerPoint and reporting skillsExcellent interpersonal skills to deal effectively with patients, physicians, clinicians and administratorsExcellent organizational skills and self-management skills to independently manage work flowAbility to prioritizeMeticulous attention to detailKnowledge of medical terminologyKnowledge of good clinical practice, FDA, OHRP, HIPAA policiesExperience using Microsoft Office SuiteCertification through either ACRP or SoCRA highly preferred