Locatedin Nashville, Tennessee, and operating at a global crossroads of teaching,discovery and patient care, VUMC is a community of individuals whocome to work each day with the simple aim of changing the world. It is a placewhere your expertise will be valued, your knowledge expanded and your abilitieschallenged. It is a place where your diversity â of culture, thinking, learningand leading â is sought and celebrated. It is a place where employees know theyare part of something that is bigger than themselves, take exceptional pride intheir work and never settle for what was good enough yesterday. Vanderbiltâs mission is to advancehealth and wellness through preeminent programs in patient care, education, andresearch.
JOBSUMMARY: With guidance and training, is responsible forcoordinating the approval processes and conduct of research protocols, suchthat the integrity and quality of the clinical/translational research ismaintained and the research is conducted in accordance with Good ClinicalPractice Guidelines, federal and sponsor regulations and guidelines, VanderbiltPolicy and Procedure and research protocols. Manages screening, implementsrecruitment procedures, consenting, enrollment, randomization and study conductfrom planning through study closeout. Performs or implements processes toassure study-related procedures are performed as required and objectives andtimelines are met. Maintains accurate and timely documentation andcommunication with Investigators, participants, IRB, sponsors and otherresearch related entities.
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
Because weare committed to providing the best in patient care, education and research, weare proud of our recent accomplishments:
Â·US News & World Report:#1 Hospital in Tennessee, #1 Health CareProvider in Nashville, #1 Audiology (BillWilkerson Center), 12 adult and 10 pediatric clinical specialties ranked amongthe nation's best, #15 Education and Training
Â·Truven Health Analytics:among the top 50 cardiovascular hospitals inthe U.S.
Â·Becker's Hospital Review:one of the "100 Greatest Hospitals inAmerica"
Â·The Leapfrog Group:grade "A" in Hospital Safety Score
Â·National Institutes of Health:among the top 10 grant awardees for medicalresearch in the US
Â·Magnet Recognition Program:Vanderbilt nurses are the only group honoredin Tennessee
Â·Nashville Business Journal:Middle Tennessee's healthiest employer
Â·American Hospital Association:among the 100 "MostWired" medical systems in the US
Vanderbilt University Medical Center is a comprehensive health care facility dedicated to patient care, research, and biomedical education. Our reputation for excellence in these areas has made us a major center for patient referrals from throughout the Mid-South. Each year, people throughout Tennessee and the Southeast choose Vanderbilt University Medical Center for their health care because of o...ur leadership in medical science and our dedication to treating patients with dignity and compassion.The mission of Vanderbilt University Medical Center is to advance health and wellness through preeminent programs in patient care, education, and research.