Clinical Translational Research Coordinator II

JOB SUMMARY:
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 within all policies, under occasional guidance.

KEY RESPONSIBILITIES:

• Knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporation of them in the conduct of research and care of participants
• Possesses a basic awareness of the Federal regulations governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH guidelines, and HIPAA regulations
• Responsible for the necessary regulatory preparation and submissions of research protocols- amendments, continuing review applications, protocol deviations and adverse event reports
• With assistance of Principal Investigators or Sub-Investigators, pre-screen, screening and able to assesses and evaluates potential subjects pertinent medical and historical information to ensure only eligible subjects are enrolled in clinical/translational trials and maintain eligibility for continued participation
• Understands, implements, and follows a clinical/translational study protocol and can conduct multiple studies independently, obtaining training or training others to safely and accurately perform or assess required protocol procedures
• Works collaboratively with other staff to complete research protocols activities, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in EPIC, conducting surveys, interviews, laboratory, and diagnostic studies, tracking medication usage and other protocol specific investigational procedures
• Actively participates in the informed consenting and documenting process, detailed explain schedule of events ensuring that human subjects, their families, and other health care providers clearly understand what is expected of and from them while participating in a clinical/translational trial
• 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 public responsible for, or concerned about, protections for human participants of research and through ongoing monitoring of trial processes and participants
• 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
• Actively Participates in the determination of eligibility and 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
• Sound knowledge of 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
• Responsible for collecting, labelling, and storing study specimens based on the protocol. 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
• 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 nurses conducting clinical research
• Participates in and maintains professional certifications, licensure and credentialing as required of nurses employed at Vanderbilt (i.e., CPR certification)
• Identifies areas for potential improvement and escalates appropriates

BASIC QUALIFICATIONS

• Graduate of an approved discipline specific program (or equivalent experience) and 1 year experience
  Licensure, Certification, and/or Registration (LCR):
• Licensed Practical Nurse Preferred (Clear and Active License)

Department Summary:

Department Summary:
The Division of Allergy, Pulmonary and Critical Care is directed by Dr. Timothy Blackwell and its mission is to:

• deliver world-class clinical care to patients with allergic diseases, pulmonary conditions, and critical illness through employing a collaborative, multi-disciplinary approach with a wide range of clinical programs.
• lead in the development of cutting-edge, patient-focused research that extends from basic discoveries to clinical implementation.
• provide state-of-the-art education and training including a strong fellowship program to inspire and nurture the next generation of leaders in allergy and immunology, pulmonary medicine, and critical care.

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 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 a 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.