Clinical Trials Coordinator II - Department of Plastic Surgery
In your pivotal role as Clinical Research Projects Coordinator, you will support the activities of the Clinical Research Faculty and staff through project tracking and navigation, assistance with clinical trials, and administrative support for the production and submission of research publications and grant applications. You will be 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. You will manage screening, implement recruitment procedures, consent, enrollment, randomization and study conduct from planning through study closeout. You will perform or implement processes to assure study-related procedures are performed as required and objectives and timelines are met. You will maintain accurate and timely documentation and communication with Investigators, participants, IRB, sponsors and other research related entities.
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
Clinical Trial Assistance
Participate in sponsor and internal study-related meetings when applicable
Assist with scheduling visits and providing appropriate access to external vendors and monitors
Support local study recruitment and enrollment reporting
Support maintenance of the overall structure of electronic Trial Master Files (eTMF's) and assist with quality control as appropriate
Receive study documents, review for completion, and accuracy and submit to the eTMF; audit existing data in eTMF for expiring and missing documents, signatures, and completeness
Examine subject files, extract research-related patient data from the Electronic Medical Record and log study metrics in study-related databases and Case Report Forms
Assist with the maintenance and filing of all forms of regulatory documents including consent forms, master subject logs, Key Study Personnel lists, licenses and CV's and appropriate correspondence
Assist in the maintenance of operational study materials including but not limited to presentations, protocols, status reports, project management plans, Gantt Charts, operating guidelines, internal policies and procedures, manuscripts, and posters
Distribute clinical trial related materials to sites, clinical staff, and/or study team members
May support a variety of areas, projects and programs within Plastic Surgery Research.
Participate in internal meetings and assist in preparation of agendas, minutes, and tracking of action items
Responsible for departmental support including formatting of manuscripts for journal submission and grant applications.
Electronic submission of manuscripts to journals and tracking of submission status.
Draft and edit policies, guidance documents, and other reference material as appropriate.
Update web and social media content to reflect project developments.
* Bachelor's Degree (or equivalent experience) and 2 years experience
Experience with Microsoft Office
Knowledge of medical terminology and/or medical background
Project management with long-term projects
Working with data, including preparation of quality graphs, tables, and figures.
Good professional writing and communication
Good organizational and prioritizing capabilities
Critical thinking abilities
Highly Desirable Qualifications
Clinical trial/ research experience including experience with databases such as REDCap, a Clinical Trial Management System (CTMS) or Microsoft Access.
Familiarity with IRB processing
Knowledge/experience with clinicaltrials.gov (not required)
Scientific writing/ editing experience
Familiar with journal submission process
Good presentation and PowerPoint skills
Experience working within an academic medical center
Previous clinical trial internship
* Day Shift/Non-Exempt Position
The Department of Plastic Surgery, within the Section of Surgical Sciences, is a vibrant and growing department. Our clinical team has a robust clinical practice and provides a variety of Plastic Surgery related care and partner with many other services within VUMC. We are also proud of our highly respected and competitive residency and fellowship programs, as well as our advanced research initiatives. Research is a vital part of Plastic Surgery at VUMC, and it is powered by research fellows, attending physicians, surgical faculty, staff, and other collaborators and colleagues from various disciplines.
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.
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
* T ruven Health Analytics: among the top 100 hospitals in the US
* Be cker'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
* 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
Internal Number: 1909881
About Vanderbilt Health
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.