JOB SUMMARY

With guidance and training, is responsible for coordinating the approval processes and conduct of research protocols, such that
the integrity and quality of the clinical/translational research is maintained and the research is conducted in accordance with
Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research
protocols. Manages screening, implements recruitment procedures, consenting, enrollment, randomization and study conduct
from planning through study closeout. Performs or implements processes to assure study-related procedures are performed as
required and objectives and timelines are met. Maintains accurate and timely documentation and communication with
Investigators, participants, IRB, sponsors and other research related entities.

KEY RESPONSIBILITIES

• Conveys a basic knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in the conduct of research:
• Possesses a basic awareness of the Federal regulations and guidelines governing the protection of human subjects (e.g.,FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations), before engaging in human subjects research
• With assistance, prepares and processes new IRB research proposals, amendments, continuing review applications and adverse event reports according to institutional and departmental policies and procedures and federal regulations
• Communicates a basic knowledge and understanding of the management and implementation of clinical/translational research operations
• Exhibits the capability to understand and follow a clinical/translational study protocol, obtaining training and seeking assistance when needed, to safely and accurately perform or assess required protocol procedures. Uses coordination skills and works collaboratively with study participants, other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in StarPanel, conducting interviews and laboratory and diagnostic studies, tracking medication usage and other protocol specific investigational procedures
• Prepares and maintains documents required to be maintained and available internally and for regulatory authorities and/or the sponsor prior to, during and after the conduct of a clinical/translational trial. Participates in periodic site visits from sponsor, regulatory authorities and others to review research, source documentation and research procedures
• Procures equipment and supplies needed to fulfill project requirements
• Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements
• Records data from source documentation and/or participant interaction onto case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness and timeliness. Attends to query resolution in a timely manner. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice
• Familiar with the safety reporting requirements of the study protocol, FDA and other regulatory bodies. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes
• Performs packaging and ships study specimens (blood, urine, etc.) to the sponsor or laboratory in accordance with sponsor and shipping guidelines and regulations, maintaining appropriate documentation
• With direction assists with study completion, study closeout and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports
• With supervision, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to
  maintain clinical trial billing compliance
• Collaboratively participates in study team meetings. 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 and through ongoing monitoring of
  trial processes and participants
• With guidance, assesses and evaluates potential participants pertinent medical and historical information to ensure only
  appropriate subjects are enrolled in clinical/translational trials and remain eligible for continued participation. Engages in
  open and positive communication with study participants and coworkers
• 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/translational
  trial
• Encourages open communication with participants by providing them with contact information and being available to
  answer, address or refer their calls
• With direction, performs or instructs others in performing procedures for research as they are described in the protocol,
  deviating from the protocol only when a subject's safety is at risk and in a timely manner reports all deviations from the
  protocol to the Principal Investigator and/or senior personnel who will determine if a protocol amendment or other
  safety reporting to appropriate funding/regulatory agencies is required
• Utilizes or obtains 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
• Actively identifies and participates in training, education, and development activities to improve own knowledge and
  performance to sustain and enhance professional development. Pursues avenues to continue education (i.e., in-services,
  seminars, etc.)
• Demonstrates initiative for continuous learning, both self-directed and as evidenced by attendance of educational and
  professional development opportunities. Actively seeks new learning opportunities, seeing learning as part of work
• Engages in a minimum of 5 hours of continuous, job-related educational activities annually or pursuing an advanced
  career-related academic education or certification
• Participates in and maintains certifications, licensure and credentialing as required by Vanderbilt, the department and
  Sponsor
• Participates in research related programs, such as the Clinical/Translational Research Staff Council, by reviewing
  information and by attending meetings open to research staff
• Furthers knowledge base by attending a Basic Research 101 within first three months of employment date

*** Minimum Qualifications Required ***

Bachelor's Degree (or equivalent experience) and < 1 year experience

Prior to advancing to a Clinical/Translational Research Coordinator II, must have completed a Research 101 course such as RSS Boot camp

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.

• 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: Standing: Remaining on one's feet without moving.
• 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
• Frequent: Carrying under 35 lbs: Transporting an object holding in hands, arms or shoulders, with help of coworkers or assistive device.
• Frequent: Sitting: Remaining in seated position
• Frequent: Walking: Moving about on foot.
• Frequent: Lifting under 35 lbs: Raising and lowering objects under 35 lbs from one level to another
• Frequent: Reaching below shoulders: Extending arms in any direction below shoulders.
• Frequent: Handling: Seizing, holding, grasping, turning or otherwise working with hand or hands.
• Continuous: Fingering: Picking, pinching, gripping, working primarily with fingers requiring fine manipulation.
• Continuous: Bimanual Dexterity: Requiring the use of both hands.

• Occasional: Smell: Ability to detect and identify odors.
• Occasional: Feeling: Ability to perceive size, shape, temperature, texture by touch with fingertips.
• Continuous: Auditory: Perceiving the variances of sounds, tones and pitches and able to focus on single source of auditory information
• 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.
• Continuous: Communication: Expressing or exchanging written/verbal/electronic information.

• 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.