Description Role Summary: 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.
Department Summary: The Division of Allergy, Pulmonary and Critical Care is directed by Dr. Timothy Blackwell and is composed of almost 90 faculty and over 150 staff members, serving a wide range of clinical programs, clinical and basic science research, and a strong Pulmonary and Critical Care Fellowship Program. It has over 75 current funded research grants including large multidisciplinary and training grants. The Division has activities in two hospitals, Vanderbilt University Hospital and the Nashville Veterans Administration Hospital.
Work Schedule: Monday - Friday, normal daytime business hours
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* 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.
Key Responsibilities: - Knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research
- Knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations
- Proficiently 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
- Knowledge and understanding of the implementation, coordination, management and reporting of clinical/translational research operations
- Understanding and capability to accurately and compliantly perform the procedures required of each study protocol, working collaboratively with study participants, other staff and departments, in safely and accurately 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, etc. Ability to identify and troubleshoot problems
- 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
- Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites, if required)
- Participates in the determination of eligible candidates for study participation, assuring participants fulfill eligibility requirements. Strives to ensure studies are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation
- 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. Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents and research procedures
- Knowledgeable of the safety reporting requirements of the study protocol, IRB, 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, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports investigators, department administration and funding agencies
- 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
- 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, address or refer 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
- Utilizes or acquires 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 ensure awareness of the latest information available to coordinators conducting clinical/translational research (i.e., literature searchers, research seminars, in-services, 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 10 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 and its activities by submitting issues or suggesting solutions, and reviewing Council information, by attending meetings open to research staff and by sharing information with other research personnel
- Furthers knowledge by completing more advanced job-related educations (such as Research Support Services Boot camp Follow-up). Actively seeks new learning opportunities, seeing learning as a part of work. Develops and achieves personal and profess ional goals
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