Vanderbilt University Medical Center Clin/Tran Research Coord II (Pediatric Infectious Disease) in Nashville, Tennessee

Clin/Tran Research Coord II (Pediatric InfectiousDisease)

1808584

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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.

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Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's leading children's hospitals. We treat and help prevent all health issues ranging from colds and broken bones to heart disease and cancer.

The world-class facilities at Children's Hospital are a testament to our community's dedication to the health of children. Constructed in 2004 and expanded in 2012, our 271-bed hospital is a child-friendly place built on the science of healing.

A building alone does not make a great hospital. Our exceptional medical teams and the generous support of people like you enable us to provide every child who comes to us with the hope of improved health. Children's Hospital is a nonprofit facility. No child who needs our services is denied care on the basis of limited ability to pay.

Many of our doctors and surgeons are nationally recognized researchers who are finding new ways to cure and prevent childhood diseases. Their work preventing and treating premature birth, cancer, heart disease, spina bifida, and many other conditions is an investment in the future. We are at an important crossroads in child health. Our commitment to research and advocacy positions us to bring the promise of good health to children and families in our community and to share that hope with the world.

YourRole :

Responsible for coordinating the approval processes and conduct of research protocols, assuring that the integrity and quality of the research is maintained and that 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, consent, 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:

  • Knowledge andunderstanding of policies, procedures, and regulations governing humansubject's research and incorporates them in securing approval for and theconduct of research

  • Knowledge andunderstanding of the Federal regulations and guidelines governing theprotection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAAregulations

  • Proficientlyprepares and processes new IRB research proposals, amendments, continuingreview applications and adverse event reports according to institutionaland departmental policies and procedures and federal regulations

  • Knowledge andunderstanding of the implementation, coordination, management andreporting of clinical/translational research operations

  • Understandingand capability to accurately and compliantly perform the proceduresrequired of each study protocol, working collaboratively with studyparticipants, other staff and departments, in safely and accuratelyperforming study procedures such as assessing participant eligibility andrecruitment, arranging necessary schedules and procedures, completingrequired participant registration in StarPanel, conducting interviews andlaboratory and diagnostic studies, tracking medication usage, etc. Abilityto identify and troubleshoot problems

  • Accuratelyand compliantly prepares and maintains documents required to be maintainedinternally and available for regulatory authorities and/or the sponsorprior to, during and after the conduct of a clinical/translational trial.Participates in periodic site visits from sponsor, regulatory authoritiesand others to review research, source documentation and researchprocedures

  • Identifiesand procures equipment and supplies needed to fulfill project requirements(locally and across multiple sites, if required)

  • Participatesin the determination of eligible candidates for study participation,assuring participants fulfill eligibility requirements. Strives to ensurestudies are completed in a timely manner through implementing effectivescreening and recruitment strategies and completing required documentation

  • Records datafrom source documentation and/or participant interaction onto case reportforms (either paper or electronic) with awareness and attention to therequirements for accuracy, completeness and timeliness. Attends to queryresolution in a timely manner. Assures research information is collectedand stored in a manner that is compliant with regulations/policies andgood clinical practice. Participates in site visits from sponsor,regulatory authorities and others to review research, sourcedocumentation, critical documents and research procedures

  • Knowledgeableof the safety reporting requirements of the study protocol, IRB, FDA andother regulatory bodies. In a timely fashion, monitors, detects andreports adverse events meeting requirements of regulatory bodies.Coordinates activities and gathers information from a variety of sourcesto achieve stated outcomes

  • Performspackaging and ships study specimens (blood, urine, etc.) to the sponsor orlaboratory in accordance with sponsor and shipping guidelines andregulations, maintaining appropriate documentation

  • Withdirection, develops and manages study budgets, monitoring efficientinvoicing and taking appropriate action to maintain clinical trial billingcompliance, providing reports investigators, department administration andfunding agencies

  • Serves as anadvocate for human subjects by establishing and maintaining communicationwith Investigators, research staff, Sponsors, participants andrepresentatives of professional organizations, participant advocates, andthe public responsible for, or concerned about, protections for humanparticipants of research and through ongoing monitoring of trial processesand participants

  • Assesses andevaluates potential participants pertinent medical and historicalinformation to ensure only appropriate subjects are enrolled inclinical/translational trials and remain eligible for continuedparticipation

  • Participatesin the ongoing informed consent process, ensuring that human subjects,their families, and other health care providers clearly understand what isexpected of and from them in the course of participating in aclinical/translational trial

  • Engages inopen communication with participants by providing them with contactinformation and being available to answer, address or refer their calls

  • Performs orinstructs others in performing procedures for research as they aredescribed in the protocol, deviating from the protocol only when asubject's safety is at risk and reporting as required by policy,regulations or protocol, to the sponsor and regulatory agencies

  • Utilizes oracquires knowledge of disease processes to observe for and report adverseevents in a timely and accurate manner to the principal investigator andall regulatory authorities (IRB, Sponsor, FDA, NIH, etc.) as required byprotocol, policies and procedures and regulations

  • Activelyidentifies and participates in training, education, and developmentactivities to improve own knowledge and performance to sustain and enhanceprofessional development. Pursues avenues to ensure awareness of thelatest information available to coordinators conductingclinical/translational research (i.e., literature searchers, researchseminars, in-services, etc.)

  • Demonstratesinitiative for continuous learning, both self-directed and as evidenced byattendance of educational and professional development opportunities.Actively seeks new learning opportunities, seeing learning as part of work

  • Engages in aminimum of 10 hours of continuous, job-related educational activitiesannually or pursuing an advanced career-related academic education orcertification

  • Participatesin and maintains certifications, licensure and credentialing as requiredby Vanderbilt, the department and Sponsor

  • Participatesin research related programs, such as the Clinical/translational ResearchStaff Council and its activities by submitting issues or suggestingsolutions, and reviewing Council information, by attending meetings opento research staff and by sharing information with other research personnel

  • Furthersknowledge by completing more advanced job-related educations (such asResearch Support Services Boot camp Follow-up). Actively seeks newlearning opportunities, seeing learning as a part of work. Develops andachieves personal and professional goals

  • Pursuesprofessional development opportunities, including external and internaltraining.

  • Attendsregional or national industry/professional meetings, conferences, andworkshops.

PositionQualifications

Required:

Bachelor's Degree (or equivalent experience) and 2 years experience

Shift:

Variable

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 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology ( Bill Wilkerson Center at http://www.vanderbilthealth.com/billwilkerson/ ), 12 adult and 10 pediatric clinical specialties ranked among the nation's best, #15 Education and Training

· Truven Health Analytics: among the top 50 cardiovascular hospitals in the U.S.

· Becker's Hospital Review: one of the "100 Greatest Hospitals in America"

· The Leapfrog Group: grade "A" in Hospital Safety Score

· National Institutes of Health: among the top 10 grant awardees for medical research in the US

· Magnet Recognition Program: Vanderbilt nurses are the only group honored in Tennessee

· Nashville Business Journal: Middle Tennessee's healthiest employer

· American Hospital Association: among the 100 "Most Wired" medical systems in the US

Bachelor's Degree (or equivalent experience) and 2 years experience

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

Additional Qualification Information:

  • Prior to advancing to a Clinical/Translational Research Coordinator II, 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.

Physical Requirements/Strengths needed & Physical Demands:

Movement

  • Occasional: Sitting: Remaining in seated position

  • Occasional: Standing: Remaining on one's feet without moving.

  • Occasional: Walking: Moving about on foot.

  • 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.

Sensory

  • Occasional: 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.

  • Frequent: Noise: May include exposure to occupational noise levels which equal or exceed an 8-hr time-weighted average of 85 decibels, requiring enrollment in VUMC's Hearing Conservation Program which includes training, use of hearing protection, and periodic audiometry.

  • Continuous: Communication: Expressing or exchanging written/verbal/electronic information.

Environmental Conditions

Job Research

Organization: Pediatric Infectious Disease 104606

Title: Clin/Tran Research Coord II (Pediatric Infectious Disease)

Location: TN-Nashville-Medical Center North (MCN)

Requisition ID: 1808584

Vanderbilt University Medical Center is committed to principles of equal opportunity and affirmative action.