The Vanderbilt Memory &Alzheimerâs Center seeks a full-time Research Coordinator II for a large,longitudinal NIH-funded clinical research study. The prospective study isfocused on identifying risk factors for abnormal cognitive aging, includingmild cognitive impairment and Alzheimerâs disease, with an emphasis on vascularhealth. The study has enrolled over 300 older adults who are seen every otheryear for a comprehensive visit, including blood work, cognitive assessment,neuroimaging, vascular imaging, and biomarker acquisition. The ResearchCoordinator II is responsible for coordinating or implementing processes toassure study-related procedures are performed as required and objectives andtimelines are met. This position maintains accurate and timely documentationand communication with Investigators, participants, IRB, sponsors and otherresearch related entities. This position provides an excellent opportunity togain clinical research experience in Alzheimerâs disease, neuroimaging, andneuropsychology while working as part of an interdisciplinary team of expertsin neuropsychology, neurology, neuroimaging, cardiology, and biostatistics.
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 professional goals
Â·Bachelors Diploma (or equivalent experience) and 2 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; applicant/new hire must complete a Research 101 course within six (6) months of hire.
Â·Day Shift/Non-Exempt Position
Welcome to the Vanderbilt Memory & Alzheimerâs Center. Our Center was established in January 2012 to advance the scientific communityâs understanding of risk factors, early diagnostic markers, and prevention and treatment methods for memory loss and unhealthy cognitive aging, including mild cognitive impairment, Alzheimerâs disease, and related disorders.
The Vanderbilt Memory & Alzheimerâs Center is committed to reducing the public health burden of Alzheimerâs 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 â of culture, thinking, learning and leading â 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. Vanderbiltâs mission is to advance health and wellness through preeminent programs in patient care, education, and research.
Because we are committed to providing the best in patient care, education and research, we are proud of our recent accomplishments:
Â·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
Â·Truven Health Analytics: among the top 100 hospitals in the US
Â·Becker's Hospital Review: one of the "100 Greatest Hospitals in America"
Â·The Leapfrog Group: grade "A" in Hospital Safety Score
Â·National Institutes of Health: among the top 10 grant awardees for medical research in the US
Â·American Association for the Advancement of Science: 12 faculty members elected fellows in 2014
Â·Magnet Recognition Program: Vanderbilt nurses are the only group honored in Middle Tennessee
Â·Nashville Business Journal: Middle Tennessee's healthiest employer
Â·American Hospital Association: among the 100 "Most Wired" 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 our 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.