Career Center

JOB SUMMARY:
Assures the integrity and quality of clinical research trials are maintained with some guidance. Plans and implements recruitment procedures, manages enrollment of the trial, and ensures compliance with protocols.

Key Responsibilities

Preparation -

• Knowledgeable of protocols to determine specific criteria for eligibility or exclusion.
• Sets up timeline of tests and required procedures.
• Prepares kits for procedures and labels tubes with specific times and dates for collection.
• Prepares and stores critical documents required to be maintained and provided to the sponsor prior to, during and after the conduct of a clinical trial
• Assesses and evaluates potential participants pertinent medical and historical information to ensure only appropriate subjects are enrolled in clinical trials
• Knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporation of them in the conduct of research and care of participants
• Possesses a basic awareness of the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations
• Possesses a basic awareness of the Vanderbilt policies and regulations governing the protection of human subjects
• Knowledge and understanding of the management and implementation of clinical trial operations
• Understanding and capability to perform the procedures required of each study protocol (obtains training needed to safely and accurately perform or assess required procedures)
• Maintains open and positive communications with investigators, participants, co-workers, other departments and sponsors.
• Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, Sponsors, participants and representatives of professional organizations, participant advocates, and the public responsible for, or concerned about, protections for human participants of research
• Understands standard of care versus research and continually assesses need for additional protections for the protection of research participants and the accuracy and appropriateness of research data.

Collecting and Coordinating -

• Participates in the determination of eligibility and recruits candidates for study participation. Troubleshoots trial recruitment strategies to ensure trials are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation
• Collects and monitors all study patients records to document treatments and outcomes as required by the protocol
• Reports all adverse reactions according to VUMC and protocol guidelines
• Assists with monitoring compliance with protocol and regulations
• Ensures deadlines are met for study
• Informs nurse of tests and procedures as needed
• Meets with and assists in response to sponsors and monitors to ensure compliance with protocol and applicable regulations.
• Conducts follow-up of study patients.
• Calls or sends questionnaires to patient to check outcomes, survival rate, and quality of life.
• Provides education and training to appropriate personnel and participants in research specific methodology and procedures
• Utilizes nursing skills and processes to identify participant and study problems and utilizes problem solving skills to identify solutions, following through to implement solutions, and assuring goals are met
• Participates in the ongoing informed consent process, ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them in the course of participating in a clinical trial
• Utilizes nursing skills to complete research protocols including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication dispensing and other protocol specific investigational procedures
• Independently uses and documents the nursing process to plan, deliver and evaluate goal focused, individualized, safe, age-specific care as it relates to uncomplicated research participants and with assistance for complicated research participants
• Performs procedures for research as they are described in the protocol, deviating from the protocol only when a subject's safety is at risk and reports all deviations from the protocol to the Principal Investigator and/or senior personnel who will determine of a protocol amendment or other safety assessments are required
• Utilizes knowledge of disease processes to observe for and report adverse events in a timely and accurate manner to the principal investigator and all regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required by protocol, policies and procedures and regulations

Maintaining Records

• Abstracts and records all patient data essential to the study onto required case report forms.
• Inputs all pertinent patient data into database accurately
• Ensures complete source documentation in record
• Quality control of data and records to ensure compliance with protocol.
• Participates in periodic remote monitoring visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures

*** Minimum Qualifications Required ***

Graduate of an approved discipline specific program (or equivalent experience) and < 1 year experience

Licensure, Certification, and/or Registration (LCR):

• Registered Nurse Required

Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded and your abilities challenged. It is a place where your diversity -- of culture, thinking, learning and leading -- is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research.

VUMC Recent Accomplishments

Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:

* US News & World Report: #1 Adult Hospital in Tennessee and metropolitan Nashville, named to the Best Hospitals Honor Roll of the top 20 adult hospitals, 10 nationally ranked adult specialty programs, with 3 specialties rated in the top 10 nationally, Monroe Carell Jr. Children's Hospital at Vanderbilt named as one of the Best Children's Hospital in the nation, with 10 out of 10 pediatric specialties nationally ranked.

* Healthcare's Most Wired: Among the nation's 100 "most-wired" hospitals and health systems for its efforts in innovative medical technology.

* Becker's Hospital Review: named as one of the "100 Great Hospitals in America", in the roster of 100 Hospitals and Health Systems with Great Oncology Programs and to its list of the 100 Hospitals with Great Heart Programs.

* The Leapfrog Group: One of only 10 children's hospitals in the to be named at Leapfrog Top Hospital.

* American Association for the Advancement of Science: The School of Medicine has 112 elected fellows

* Magnet Recognition Program: Received our third consecutive Magnet designations.

* National Academy of Medicine: 22 members, elected by their peers in recognition of outstanding achievement

* Human Rights Campaign Healthcare Equality Index: 6^th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ Healthcare Equality

Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and to the principles of equal opportunity and affirmative action. EOE/AA/Women/Minority/Vets/Disabled

Physical Requirements/Strengths needed & Physical Demands:

• Light Work category requiring exertion up to 20 lbs. of force occasionally and uses negligible amounts of force to move objects.

Movement

• Occasional: Lifting over 35 lbs: Raising and lowering objects from one level to another, includes upward pulling over 35 lbs, with help of coworkers or assistive device
• Occasional: Carrying under 35 lbs: Transporting an object holding in hands, arms or shoulders, with help of coworkers or assistive device.
• Occasional: Balancing: Maintaining body equilibrium to prevent falling when walking, standing, crouching or maneuvering self, patient and equipment simultaneously while working in large and small spaces
• Occasional: Climbing: Ascending or descending stairs/ramps using feet and legs and/or hands and arms.
• Occasional: Kneeling:Bending legs at knees to come to rest on knee or knees.
• Occasional: Crouching/Squatting: Bending body downward and forward by bending legs and spine.Reaching above shoulders: Extending arms in any direction above shoulders.
• Occasional: Reaching above shoulders: Extending arms in any direction above shoulders.
• Occasional: Sitting: Remaining in seated position
• Occasional: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another
• Occasional: Push/Pull: Exerting force to move objects away from or toward.
• Occasional: Bending/Stooping: Trunk bending downward and forward by bending spine at waist requiring full use of lower extremities and back muscles
• Occasional: Reaching below shoulders: Extending arms in any direction below shoulders.
• Occasional: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.
• Frequent: Fingering: Picking, pinching, gripping, working primarily with fingers requiring fine manipulation.
• Frequent: Bimanual Dexterity: Requiring the use of both hands.
• Frequent: Standing: Remaining on one's feet without moving.
• Frequent: Walking: Moving about on foot.

Sensory

• Frequent: Communication: Expressing or exchanging written/verbal/electronic information.
• Continuous: Auditory: Perceiving the variances of sounds, tones and pitches and able to focus on single source of auditory information
• Continuous: Smell: Ability to detect and identify odors.
• Continuous: Feeling: Ability to perceive size, shape, temperature, texture by touch with fingertips.
• Continuous: Vision: Clarity of near vision at 20 inches or less and far vision at 20 feet or more with depth perception, peripheral vision, color vision.

Environmental Conditions

• Occasional: Chemicals and Gasses: Medications, cleaning chemicals, oxygen, other medical gases used in work area.
• Occasional: Radiation: May be exposed to occupational radiation, requiring enrollment in VUMC's Radiation Safety Program which includes training, use of personal protective equipment with lead shielding, and personal dose monitoring.
• Frequent: Pathogens: Risk of exposure to bloodborne pathogens and other contagious illnesses.