Clinical Translational Research Coordinator I (Memory/Alzheimer Center)
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.
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
* 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
* Day Shift/Non-Exempt Position
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 .
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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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Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period.Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.As th...e largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.