Clinical Research Assistant

JOB TITLE: Research AssistantPOSITION SUMMARY:Experienced Medical Assistant or Research Assistant needed to contribute to Academic Urology's growing research department. Research Assistant (RA) roles often transition to Clinical Research Coordinator (CRC) roles and open the door to many other career opportunities within the industry. Research Assistants support the Clinical Research Team with subject recruitment, diagnostic testing, laboratory specimen collection, communications with patients, study sponsors, and investigators, and other interesting research related roles.You will work closely with our Study Coordinators, Clinical Research Site Manager, Principal Investigators (PI) and Sub-Investigators (Sub-Is) on various clinical research studies.JOB RELATIONSHIPS:Reports to the Director of Clinical Research, VP of Clinical Research, Market President, and all the physicians at Academic UrologyAble to collaborate with experienced patient navigators, IT, and data management teamsROLE QUALIFICATIONS: (experience, education, and skills)Must be willing to gain a thorough knowledge and follow strict adherence of all clinical study protocols.Develop an understanding of and demonstrate Good Clinical Practices (GCPs), learn and comply with all FDA clinical trial and IRB rules and regulationsMust have > 1 year experience as a medical assistant or research assistant.Urology based clinical experience preferredShould possess or develop proficiency in computer software use, including Microsoft Office, EMR and Practice Management systems, and study specific EDC and IVRS systemsEffective time management and the ability to prioritize workExcellent communication skills and the ability to interact with all levels of management, staff, and physicians in person, virtually, and in writingAbility to be flexible with the day-to-day job requirements to facilitate a successful workflow in clinicESSENTIAL JOB RESPONSIBLITIES:Review and follow Urology Alliance Standard Operating ProceduresRead and understand specific requirements of each study protocol and informed consent formWorks with study coordinators and other research team members to complete protocol specific procedures and documentationAssists in clinic and protocol administration duties including but not limited to:Explain the purpose, risks, and benefits of clinical trial participationScreen potential candidates in a timely and accurate mannerEnsure that study patients understand the information presented and agree to the protocol requirementsObtain and maintain consent of patients prior to any study-related procedures being performed and with the highest ethical standardsProvide instructions to patients to ensure proper protocol complianceDistribute study medications in compliance with protocol randomization requirementsLearn and understand lab procedures and obtain and process study related lab specimens according to the study specific manuals (lab and procedural)Use approved source documents; obtain protocol-specific data to complete and maintain source documents and case report forms (including electronic data capture – EDC) in accordance with applicable regulations and sponsor requirementsPerform study-specific readings and measurements including but not limited to:Vital signsECGUrine Pregnancy TestUroflow, TRUS, urinalysis, cystoscopyPhotography and videographyReports irregular readings and measurements to Investigator and Lead Study CoordinatorPackage and ship laboratory specimens to study-specific destinationsComplete applicable training requirements and ongoing education as requiredMaintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc.Communicate with and support patients and their families as necessary.Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain recordsEffectively communicate with potential candidates for trials and collect metrics to track progressMust have or gain knowledge of relevant software/programsWork closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and callsAssist with the development of source documents and phone screen toolsManage ancillary supply inventory and assist with drug accountabilityMaintain HIPAA compliant communication and confidentiality, at all timesParticipate in site visits (site initiation visits, interim monitoring visits, close-out visits, etc.Assist study coordinators with necessary study close-out procedures and documentationPerforms other duties as assignedPERFORMANCE REQUIREMENTS:KnowledgeKnowledge of health care field; medical practice clinical and administrative systems, departments, and practices, including clinical financial policies and reimbursement payment requirements.Understanding of medical terminology.SkillsAbility to use multi-line phone systems and basic computer systems.Interpersonal and communication both with internal staff and external customers.Skill in evaluating and implementing study protocols and budgets.Skill in reading medical chart terminology.Time Management.AbilitiesAbility to communicate effectively with patients, staff, and external contacts via phone, in person, and through electronic mail.Elicit appropriate information for patients to clinic staff.Ability to read and understand information and ideas presented in writing.Ability to apply general rules to specific problems to produce answers that make sense – deductive reasoning.REPORTING TO THIS POSITION: No direct reports at this time, can change as department growsPHYSICAL DEMANDS AND WORK ENVIRONMENT:The physical demands and work environment characteristics described here are the representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions:Physical demands: Involves sitting approximately 90 percent of the day, walking or standing for the remainder. Work may require stooping and bending to access files, supplies, mobility to complete errands, and lifting up to 20 pounds.Work environment: Primarily office setting. Noise level in the work environment is usually moderate. Clean, well-lighted office environment. #J-18808-Ljbffr Paycom