Clinical Research Coordinator I

Job Summary:Under the general supervision of a physician and the clinical and clinical research team in an outpatient setting, the Clinical Research Coordinator I (CRC I) is responsible for executing study-related activities from study startup through closeout. All tasks are conducted in compliance with Good Clinical Practice (GCP), ALCOA-C principles, sponsor requirements, and USDP standards. The CRC I supports the Principal Investigator in the conduct of clinical trial visits, ensuring that participants are appropriately scheduled and that all protocol-specified procedures are completed accurately and in a timely manner.Duties and Responsibilities:Maintain all aspects of study protocol during recruitment, screening, enrollment, and follow-up visitsAssist the PI, and team when applicable, the informed consent process with patients and their familiesConduct and coordinate patient visits including patient demography, vitals, EKG, phlebotomy, photography, administering investigational drug, assisting PI and sub-investigators with physical exam, and scheduling appropriate follow-up visitsCommunicate frequently with contract research organizations, IRB, Sponsors, Central Lab Facilities, and other outside vendors to manage the day-to-day needs for current and prospective trialsMaintain all source documents and investigational drug accountability recordsEnter source data into EDC efficient and accuratelyMaintain regulatory documents related to ISFFollow SOPs, policies, and procedures as set forth by the companyReview EDC for accuracy and completion, and resolve queries as they ariseAssists with direct patient care procedures, as required by the study, including biopsies, surgeries, cosmetic procedures and related tasksProcess prescriptions and prior authorizations as directed by physician. Address patient and/or pharmacy questions concerning medication. Enroll patients in patient education/assistance programsEnsure necessary study related documentation and correspondence study subjects, study teams, vendors, and sponsorsScans correspondence into EMRPractices safety, environmental, and/or infection control methodsAssist clinical research manager in delegated tasksPerforms miscellaneous job-related duties as assignedProcess blood and urine samples in accordance with IATA and OSHA standardsPrepare necessary documentation for SIV, IMV, COVs and other sponsor related meetingsWorking knowledge, at minimum, of all applicable protocols. Some team members may be assigned as the primary coordinator for a specific protocol, and should therefore have in-depth knowledge of that protocolExperience Requirements:At least 1 year of research experience, preferredAt least 1 year of direct patient experience, preferredKnowledge, Skills and Abilities Requirements:Meticulously detail oriented, professional attitude, reliableOrganizational skills to support accurate record-keepingAbility to follow verbal & written instructionsInterpersonal skills to work as a team with patients and outside partiesAble to communicate effectively in English, both verbally and in writing, with proper grammar and spelling skills to avoid mistakes or misinterpretationsMathematical and analytical ability for basic to intermediate problem solvingBasic to intermediate computer operationProficiency with Microsoft Excel, Word, and OutlookSpecialty knowledge of systems relating to job functionKnowledge of state and federal regulations such as ICH GCP, IATA; general understanding of HIPAA guidelinesSupervisory Responsibilities:This position has no supervisory responsibilities.Benefits:Medical, Dental, & Vision401kPTO & Paid HolidaysCompany Paid Life InsuranceEmployee Perks Program #J-18808-Ljbffr