CLINICAL TRIALS OF TEXAS, LLC
Job Description
Job Title: PRN RN/LVN
Department: Clinical FLSA Classification: Non-Exempt I. PURPOSE: To coordinate activities and perform duties and procedures related to the start-up, conduct and close-out phases of clinical pharmaceutical and device research protocols. To obtain clean, objective and accurate data within sponsor timelines while following applicable CTT SOPs, policies and procedures, federal regulations, medical ethics, Good Clinical Practices (GCPs), International Council of Harmonization (ICH), Institutional Review Board (IRB) requirements, and in compliance with specific sponsor protocol requirements. All responsibilities should be completed in accordance with CTT’s Core Values, Mission Statement and Employee Manual.
II. JOB RELATIONSHIPS:
Reports to: Team Lead I, Team 1
Assistant Director, Team 1
Workers Supervised: None
Interrelationships: Works closely with CTT staff, patients and sponsor/contract research organization (CRO) representatives. Works frequently and to varying degrees with physicians and nursing staff at offices separate from CTT. May, from time to time, work with hospital staff members.
III. RESPONSIBILITIES: A. Represent CTT in a professional and courteous manner (verbal, written and in appearance) when interacting with CTT staff, sponsors, IRBs, patients/subjects, nursing and medical staff members of various clinics, hospitals and physician’s offices;
B. Read, understand and is able to accomplish protocol specified patient visits and procedures;
C. Clearly and concisely document patient assessments, observations, test results and other study related information per federal regulations, protocol requirements and GCPs;
D. Obtain patient informed consent according to federal regulations, GCPs and IRB requirements;
E. Complete all required training in a timely manner;
F. Complete patient visits according to protocol requirements and timelines;
G. Performs medical tests, including but not limited to, vital signs, imaging studies, electrocardiograms;
H. Administers investigational medications and performs patient assessments during clinic visits to determine presence of side effects, notifies Principal Investigator of findings/issues;
I. Perform IV/Phlebotomy to include inserting peripheral IV catheters, draw blood and draw from a line;
J. Provides patient education and medical information to study patients to ensure understanding of proper medication dosage, administration and disease treatment;
K. Maintain accurate and complete written source documentation of patient visits and protocol related activities;
L. Maintain confidentiality of patient and protocol issues as appropriate and as bound by Confidentiality Agreements with CTT, between CTT and sponsors, and between CTT and other entities, as well as HIPAA regulations;
M. Promptly report adverse events to supervisor and/or Principal Investigator/Sub-Investigator as deemed necessary;
N. Maintain ongoing communication with Team Lead I; Assistant Director, Team 1; Director, Clinical Operations; Senior VP of Operations; Principal Investigator; Sub-Investigators and other persons assisting with the trial and documents these communications according to protocol requirements and CTT policies; O. Attend required trainings in order to stay abreast of current and changing federal regulations and CTT policies;
P. Perform all study-related duties in a time- and cost-effective manner in adherence with CTT policies;
Q. Perform all duties in a safe and prudent manner;
R. Perform other duties as assigned.
IV. PHYSICAL REQUIREMENTS AND/OR ENVIRONMENTAL FACTORS:
A. Work is normally performed in a typical interior/office work environment;
B. Exposure to human bodily fluids;
C. Subject/Patient care;
D. Daily computer use;
E. Ability to properly lift up to 35 pounds and occasionally more than 35 pounds;
F. Ability to drive, and daily availability of an automobile.
- V. MINIMUM REQUIREMENTS:
Education & License:
A. Bachelor of Nursing or other Science degree preferred
B. Valid RN or LVN license from State of Texas
Experience:
A. Minimum of 1-3+ years’ experience within the field of clinical or biological research
B. Two years of recent clinical nursing experience in a hospital, clinic, or similar health care setting
C. Nursing competency skills per scope of practice (i.e., performing IV, phlebotomy, PK draws, vital signs, nursing assessments, performing ECG/EKG, administering injections, etc.)
D. American Heart Association BLS active for at least 2 years preferred
E. At least one year clinical trials research experience preferred
F. Knowledge of medical terminology, drug calculations skills, clinical medicine, clinical trials and GCP concepts.
Knowledge and Skills:
A. Demonstrates core values & all skills set required;
B. Ability to read, understand and assimilate protocol specified requirements and/or to ask appropriate questions as needed to gain knowledge and understanding;
C. Must possess a basic knowledge of research design, patient care practices, GCPs, FDA regulations and a thorough knowledge of medical terminology;
D. Possesses excellent interpersonal skills including written and oral communications;
E. Is moral and ethical in decision-making and during interaction with patients, sponsor and IRB representatives, physicians and staff at satellite clinics, and other employees;