Clin/Tran Research Coord III, Pediatric Infectious Disease
Location: Nashville, Tennessee
Academic / Research
Internal Number: 2213951
Clin/Tran Research Coord III, Pediatric Infectious Disease -2213951
:TN-Nashville-Medical Center North (MCN)
:Pediatric Infectious Disease 104606
CTRC-III Peds Infectious Disease
Complex and busy research program in search of an individual with advanced knowledge and understanding of the planning, implementation and management of research activities in a division of Infectious Disease laboratory that specializes in the identification and evaluation of respiratory and diarrheal infectious agents by molecular diagnostics. The individual in this position will be responsible for planning through completion and reporting, assuring that the processes, integrity and quality of the research are assessed and maintained and that the studies are conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols. This role will also serve as a resource for inquiries and maintains communication with the investigators, participants, sponsors, IRBs, DSMBs and other research related entities. The main job will be to oversee and to lead viral surveillance studies operations and training, and oversee data integrity.
Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research, and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research. Compliantly, accurately and proficiently prepares, processes and manages new research proposals, amendments, continuing review applications, adverse event reports, and budgets
Advanced knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations
Advanced knowledge of the policies and procedures and requirements of Vanderbilt departments involved in the approval of research (IRB, grants, contracts, finance, etc.) and the ability to proficiently and compliantly maneuver though the approval processes and then assure compliance throughout the research process
Advanced knowledge and understanding of the management and implementation of clinical/translational research operations
Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently, obtaining training or training others to safely and accurately perform or assess required protocol procedures. Works collaboratively with 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. Problem solves when needed
Accurately and compliantly prepares and maintains documents required to be maintained internally and available 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. Participates in data quality assurance reviews
Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
Participates in the determination of eligibility and recruits candidates for study participation. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation in an accurate and timely manner
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. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Attends to query resolution in a timely manner. Participates in the development of data collection tools
Receives and tracks receipt and status of study specimens from multiple sites. 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
Responsible for study completion processes including data lock, study closeout, reporting 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 and assuring archival of appropriate/required documentation
Utilizes coordination skills to complete all research protocols, including patient recruitment, screening, scheduling and organizing of study visits, enrollment, assessments, interviews, laboratory and diagnostic studies, medication tracking and other protocol specific investigational procedures
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
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
Engages in open communication with participants by providing them with contact information and being available to answer their calls
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 reporting as required by policy, regulations or protocol, to the sponsor and regulatory agencies
Actively identifies the need for and participates in training, education, and development activities to improve own knowledge and that of the research department and to learn about and improve research related processes (i.e., research seminars, in-services, etc.)
Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities by serving as a department representative, submitting issues or suggesting solutions, and reviewing CTRSC meeting Council information summaries, attending meetings open to research staff and by sharing information with other research personnel
** Minimum Qualifications Required **
Bachelor's Degree (or equivalent experience) (Required) and 3 years of experience (Required)
View how Vanderbilt Health employees celebrate the difference they make every day:
Discover Vanderbilt University Medical Center:
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: 6th year in a row that Vanderbilt University Medical Center was a Leader in LGBTQ
Additional Qualification Information:
Prior to advancing to a Clinical/Translational Research Coordinator III must have completed a Research 101 course such as RSS Boot camp; applicant/new hire must complete a Research 101 course within six (6) months of hire.
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.
Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period. Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.As t...he largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.