Clinical Research Assistant

Clinical Research AssistantThe Clinical Research Assistant (CRA) will assist in the conduct of clinical research activities, including participant recruitment, study documentation, data collection and entry, scheduling, and administrative tasks.This position will work closely with, and under the direction of the Principal Investigator (PI) and research team and will perform duties consistent with training and assigned responsibilities, and delegation.Other responsibilities include participating in research team meetings, communicating with internal and external research team members, and providing organizational and operational support for new and ongoing clinical research studies.Under general supervision, the Clinical Research Assistant will assist research staff with a variety of tasks to support the accurate, efficient, and compliant conduct of clinical research studies.Responsibilities may vary based on study assignment, training, and delegated responsibilities.Study Operations:Support the day-to-day conduct of new and ongoing trials under the direction of the Principal Investigator (PI), research team and in line with the protocol.Screen potential participants for research studies and collaborate with the PI, Clinical Research Nurse (CRN), or Clinical Research Coordinator (CRC) for final approval of the potential study participant as a candidate for the studyAssist with scheduling and study visit coordination, including preparing for and supporting study visits, procedures, and other study-related activitiesConducts timely telephone follow-up calls with study participants and document communications in the appropriate place in accordance with the protocolAssist with tracking enrollment, study milestones, outstanding tasks, and visit requirementsAssist with study supplies, laboratory kits, equipment, and other study materialsAssist with the preparation of documents and materials needed for study initiation, monitoring and close-out visits with sponsors and/or Clinical Research Organization (CROs), including clerical support, copying, and gathering informationRegulatory & Compliance:Assist with the preparation and submission of regulatory documents to the Institutional Review Board (IRB)Assist with organizing and maintaining regulatory and essential study documentation in accordance with ALCOA+ principles and study requirements, as directed by Supervisor, CRN, or CRCAssist the research team in preparation for sponsor/CRO monitoring visits, audits, and regulatory inspectionsPerform assigned responsibilities in accordance with study protocols, institutional policies, Standard Operating Procedures (SOPs), ICH-GCP, and applicable regulatory requirementsData Management:Obtain medical records and other source documentation required to complete CRFs and study documentationAssist with study data collection, entry, verification, and maintenance in Electronic Data Capture (EDC) systems and other designated databasesAssist with the upload of study-related images and imaging data to designated study imaging portalsAssist study teams with data query resolution and follow-up on outstanding data issuesMaintain study trackers, screening and enrollment logs, visit logs, and other study-related records as assignedStudy Logistics & Specimen Management:Prepare and organize study research laboratory kits and materialsCoordinate research specimen collection, processing, storage, and deliveryProcess, prepare, package, and ship blood, saliva, tumor tissue, and other research specimens in accordance with study protocols, laboratory requirements, and shipping procedures, assist with hospital and campus research-related pickups and deliveriesMaintain appropriate documentation and tracking of research specimens and study materialsCollaboration and Support Attend study-related meetings, conferences calls, training sessions, and other research activitiesWork collaboratively with CRCs, CRNs, PIs, and other members of the research teamCommunicate and collaborate effectively with internal partners, sponsors, CROs, laboratories, IRBs, and other external research partners as directedAssist with email correspondence, document preparation, copying, filing, and other clerical and administrative duties as requested by CRC, CRN, or SupervisorAssist with identifying routine study-related issues and promptly communicate concerns to the appropriate member of the research teamProvide organizational and administrative support to research staff to facilitate the efficient conduct of conduct clinical research studiesMaintain participant confidentiality and comply with HIPAA, institutional privacy policies, and applicable research requirementsPerform additional duties as assigned in support of clinical research operationsResearch Billing & ComplianceAssist with the review of research billing charges, including UB-04 and CMS-1500 (Form 1500) billing forms, for participants enrolled in clinical research studiesAssist with distinguishing research-related charges from standard-of-care services that may be billable to insurance or another responsible payerSupport research billing review activities as assigned and appropriately trainedOther Responsibilities Perform other duties as assigned or delegated by department leadershipExperience Required0-2 years Clinical ResearchEducation RequirementsBachelors Degree RequiredSpecial RequirementsGeneral Experience working in clinical research, public health, or behavioral science PreferredStrong interpersonal, communication, and organizational skillsAbility to manage multiple tasks, meet deadlines, and adapt to a fast-paced research environment.Salary Min ($)USD $25.00Salary Max ($)USD $42.50