"Nurse Clinician - Clinical Trials Office"

Job Summary

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

Responsibilities to include, but are not limited to:

• 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.

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 OR 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

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, & Abilities

KNOWLEDGE

Proficient in Microsoft Office and other computer software/databases. Knowledge of good clinical practices and IRB requirements. Knowledge of patient evaluation procedures and medical terminology.

SKILLS

Excellent interpersonal, written, and verbal communication skills. Detail-oriented with strong prioritization, organizational, typing, and multi-tasking skills. Basic clinical skills.

ABILITIES

Ability to maintain confidentiality. Ability to be self-motivated. Ability to interpret lab tests/x-rays. Ability to exercise sound judgment, make responsible decisions, and work independently. Ability to work flexible hours to include, early mornings, after hours, nights and weekends, and on-call two weeks per month. Ability to communicate/educate a wide variety of people using a variety of mediums and methods.

Shift/Salary/Benefits

Shift: Days; Monday - Friday (Work outside of normal business hours may be required). Salary Range: $68,500-$71,302.40 annually.