Description Clinical Translational Research Coordinator I (Memory/Alzheimer Center) Role Summary: The Vanderbilt Memory & Alzheimer's Center seeks a full-time Research Coordinator I for a large, longitudinal NIH-funded clinical research study. The prospective study is focused on identifying risk factors for abnormal cognitive aging, including mild cognitive impairment and Alzheimer's disease, with an emphasis on vascular health. The study has enrolled over 300 older adults who are seen every other year for a comprehensive visit, including blood work, cognitive assessment, neuroimaging, vascular imaging, and biomarker acquisition. The Research Coordinator I is responsible for coordinating or implementing processes to assure study-related procedures are performed as required and objectives and timelines are met. This position maintains accurate and timely documentation and communication with Investigators, participants, IRB, sponsors and other research related entities. This position provides an excellent opportunity to gain clinical research experience in Alzheimer's disease, neuroimaging, and neuropsychology while working as part of an interdisciplinary team of experts in neuropsychology, neurology, neuroimaging, cardiology, and biostatistics. Key Responsibilities: - 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
Position Qualifications: Required: * Bachelors Diploma (or equivalent experience) and <1 year experience *** 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 Position Shift: * Day Shift/Non-Exempt Position Department Summary: Welcome to the Vanderbilt Memory & Alzheimer's Center. Our Center was established in January 2012 to advance the scientific community's understanding of risk factors, early diagnostic markers, and prevention and treatment methods for memory loss and unhealthy cognitive aging, including mild cognitive impairment, Alzheimer's disease, and related disorders. The Vanderbilt Memory & Alzheimer's Center is committed to reducing the public health burden of Alzheimer's disease and mild cognitive impairment. Your support, in the form of a financial donation to our research efforts or by volunteering to participate in any one of our research programs, will move us one step closer to preventing and eliminating this devastating disease. Visit our Participate and Donate pages to learn more about how to be part of the solution . 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 Hospital in Tennessee, #1 Health Care Provider in Nashville, #1 Audiology ( Bill Wilkerson Center ), 9 adult and 9 pediatric clinical specialties ranked among the nation's best, #15 Education and Training * Truven Health Analytics: among the top 100 hospitals in the US * 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 * American Association for the Advancement of Science: 12 faculty members elected fellows in 2014 * Magnet Recognition Program: Vanderbilt nurses are the only group honored in Middle Tennessee * Nashville Business Journal: Middle Tennessee's healthiest employer * American Hospital Association: among the 100 "Most Wired" medical systems in the US *CA |
