Clinical Research Coordinator

2 weeks ago


Greenville, United States Vidant Health Full time

Job Description ECU Health About ECU HealthECU Health is a mission-driven, 1,708-bed academic health care system serving more than 1.4 million people in 29 eastern North Carolina counties. The not-for-profit system is comprised of 13,000 team members, nine hospitals and a physician group that encompasses over 1,100 academic and community providers practicing in over 180 primary and specialty clinics located in more than 130 locations.The flagship ECU Health Medical Center, a Level I Trauma Center, and ECU Health Maynard Children's Hospital serve as the primary teaching hospitals for the Brody School of Medicine at East Carolina University. ECU Health and the Brody School of Medicine share a combined academic mission to improve the health and well-being of eastern North Carolina through patient care, education and research.Position Summary The research specialist may function in finance, regulatory, compliance and/or IT-related research roles.Responsibilities Attend and actively participate in assigned meetingsDevelops and maintains a timeline for projects and facilitates project completionAssists with development and implementation of policies and procedures to ensure that the conduct and review of clinical research is in compliance with federal regulationsStays abreast of federal regulationsProvides guidance to faculty, fellows, residents, and other staff on the preparation, conduct and compliance documentation necessary for institutional, individual and research subject protections in clinical researchMeets with individual PIs at least monthly to review research activities and needsLiaison with department experts and leadership on research activities Conduct preliminary reviews of all new protocols and evaluate expedited, exempt, and full committee submission requestsOversee the screening of protocol amendments, renewals, closures and deviations as they are submitted for IRB reviewConduct literature and regulatory reviews and prepare reports for the IRB on scientific, ethical, existing and proposed regulatory topicsOversee and manage the electronic protocol submission system ensuring appropriate documentation is submitted and maintainedHandles or assists with administrative activities generally associated with the financial management of clinical trials.Processes the Clinical Trials Participant Lists daily, assuring Sponsor related charges are properly recorded for billing.Sets up New Clinical Trials accounts and work as liaison to clinical trials management, finance and accounting.Identifies appropriate research rates for procedures outlined in protocol.Analyzes study coverage analysis to assist in developing study budgets.Invoices sponsors for study related costs as defined in the Study budget; Processes stipends for payment to Study Participants.Processes incoming checks for all study accounts.Reconciles funds and identifies and resolves discrepancies while retaining documentation.Manages the research portfolios.Draft guidance documents and policies Conduct surveillance and internal auditsProvide education and training on research compliancePerform complex data extractionBuild research databasesSupport computer networksServe as an educational resource on technologyPerform other related duties incidental to the work described herein.Minimum Requirements Bachelor of Science required, preferably in medically-related field.Master's Degree is preferred Minimum of 1 year of experience in finance, regulatory, compliance, research, IT, or related fieldExperience in a hospital or health-related settingStrong communication skillsAble to demonstrate strong critical thinking, problem solving, and organizational skillsAbility to work in a team environment Proficiency with Microsoft Office toolsTechnical writing skills Working knowledge of medical terminologyOther Information Location: On siteMonday - Friday, 8:00 am - 5:00 pmPotential for on-call rotationGeneral Statement It is the goal of ECU Health and its entities to employ the most qualified individual who best matches the requirements for the vacant position.Offers of employment are subject to successful completion of all pre-employment screenings, which may include an occupational health screening, criminal record check, education, reference, and licensure verification.We value diversity and are proud to be an equal opportunity employer. Decisions of employment are made based on business needs, job requirements and applicant's qualifications without regard to race, color, religion, gender, national origin, disability status, protected veteran status, genetic information and testing, family and medical leave, sexual orientation, gender identity or expression or any other status protected by law. We prohibit retaliation against individuals who bring forth any complaint, orally or in writing, to the employer, or against any individuals who assist or participate in the investigation of any complaint.Contact Information For additional information, please contact: Angie Nichols, Talent Acquisition ConsultantECU Health Talent AcquisitionEmail: [email protected]



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