Nurse Clinician - Clinical Trials Office

Overview The Registered Nurse will be assigned to all high-risk population studies such as Pediatrics and Neonatology involving investigational drug studies and to studies involving administering IV study medication. Recruitment of new study participants to include screening and randomization; management of study documents, regulatory, data entry and assist with unfunded and/or investigator-initiated studies. Responsible for data entry into sponsor's EDC of choice and other data upload systems as well as maintenance of AU OnCore to include updating task lists, entering billing grid information into the financial console, and entering new patients as well as occurring completed visits. Serve as patient advocates, scheduling follow-up appointments, coordinate care with other departments, perform all laboratory and other tests as required by the protocol. Responsible for collection, processing, storage, and inventory of specimens for specific studies, assessing for adverse events, maintaining investigational devices, staff development and completion of regulatory paperwork as required by the FDA, study sponsor, and institutional policies and procedures. Assist with audit preparation as well as respond to internal audits from IRB. Responsibilities IV STUDY MEDICATION: RN to be assigned as needed to studies involving administering IV study medication. RECRUITMENT OF NEW STUDY PARTICIPANTS: Recruitment of new study participants to include screening and randomization; management of study documents, regulatory, data entry and assist with unfunded and/or investigator-initiated studies as assigned. DATA ENTRY: Responsible for data entry into sponsor's EDC of choice and other data upload systems as well as maintenance of AU OnCore to include updating task lists, entering billing grid information into the financial console, and entering new patients as well as occurring completed visits. PATIENT ADVOCATES: Serve as patient advocates, scheduling follow-up appointments, coordinate care with other departments, perform all laboratory and other tests as required by the protocol. Responsible for collection, processing, storage, and inventory of specimens for specific studies, assessing for adverse events, maintaining investigational devices, staff development and completion of regulatory paperwork as required by the FDA, study sponsor, and institutional policies and procedures for all assigned studies. AUDIT PREPARATION: Assist with audit preparation as well as respond to internal audits from IRB. REVIEW STUDIES: Review studies in negative balance with clinical research manager and develop strategies to prevent future occurrences. PEDIATRICS AND NEONATOLOGY: RN to be assigned to all high-risk population studies such as Pediatrics and Neonatology involving investigational drug studies. OTHER: Perform all other related duties/tasks as assigned. Qualifications Required Qualifications: Bachelor's degree in Nursing from an accredited college or university, active licensure as a Registered Nurse in the state of Georgia, and a minimum of three years of clinical experience in a specialized area. Must possess a current American Heart Association Healthcare Provider BLS/BCLS certification Alternate: Associate's degree in Nursing from an accredited college or university, licensed to practice as a Registered Nurse in the state of Georgia, and a minimum of six years of clinical experience in a specialized area. Must possess a current American Heart Association Healthcare Provider BLS/BCLS certification. Preferred Qualifications Preferred Qualifications: Completion of CITI Program (learner group 1 FDA regulated research). Certified Clinical Research Professional (CCRP) or eligibility to take certification exam. Additional years of nursing experience, specifically in a hospital setting. Pediatric nursing experience and clinical research experience are highly desirable. Knowledge, Skills, and Abilities Knowledge : Proficient in Microsoft Office and other computer software/databases. Knowledge : Knowledge of good clinical practices and IRB requirements. Knowledge : Knowledge of patient evaluation procedures and medical terminology. Skills : Excellent interpersonal, written, and verbal communication skills. Skills : Detail-oriented with strong prioritization, organizational, typing, and multi-tasking skills. Skills : Basic clinical skills. Abilities : Ability to maintain confidentiality. Abilities : Ability to be self-motivated. Abilities : Ability to interpret lab tests/x-rays. Abilities : Ability to exercise sound judgment, make responsible decisions, and work independently. Abilities : Ability to work flexible hours to include, early mornings, after hours, nights and weekends, and on-call two weeks per month. Abilities : Ability to communicate/educate a wide variety of people using a variety of mediums and methods. Shift, Salary, and Benefits Shift: Days; Monday - Friday (Work outside of normal business hours may be required). Salary Range: $68,500-$71,302.40 annually. Pay Band: B13 Salary to be commensurate with qualifications of the selected candidate within the established range (generally minimum-midpoint) of the position. Recruitment Period: Until Filled. Augusta University offers a variety of benefits to full-time benefits-eligible employees and some of our half-time (or more) employees. Benefits that may be elected could include health insurance, dental insurance, life insurance, Teachers Retirement System (or Optional Retirement Plan), as well as earned vacation time, sick leave, and 13 paid holidays. Also, our full-time employees who have been employed with us successfully for more than 6 months can be considered for the Tuition Assistance Program. Consider applying with us today! Conditions of Employment All selected candidates are required to successfully pass a Background Check review prior to starting with Augusta University. If applicable for the specific position based on the duties: the candidate will also need to have a credit check completed for Positions of Trust and or approved departmental Purchase Card usage. Motor vehicle reports are required for positions that are required to drive an Augusta University vehicle. For Faculty Hires: Final candidates will be required to provide proof of completed academic degree(s) as well as post-secondary coursework in the form of original transcript(s). Those candidates trained by a foreign institution will also be required to provide an educational/credential evaluation. All employees are responsible for ensuring the confidentiality, availability, and integrity of sensitive [patient, student, employee, financial, business, etc.] information by exercising sound judgment and adhering to cybersecurity and privacy policies during their employment and beyond. Other Information This position is also responsible for promoting a customer-friendly environment and providing superior service to our patients, students, faculty, and employees. "Augusta University is a patient-and family-centered care institution, where employees partner every day with patients and families for success." Augusta University is a tobacco-free environment, and the use of any tobacco products on any part of the campus, both inside and outside, is strictly prohibited. Equal Employment Opportunity Augusta University is proud to be an equal opportunity employer, welcoming applicants from underrepresented groups, including individuals with disabilities and veterans. How To Apply Consider applying with us today! Search for Job ID: 288814. Select University Faculty & Staff > External Applicants if you are a candidate from outside the university. Select University Faculty & Staff > Internal Applicants if you are a current university employee. If you need further assistance, please contact us at View phone number on click.appcast.io. #J-18808-Ljbffr