Location: Nashville, Tennessee
Academic / Research
Neurology Admin 30
The Behavioral and Cognitive Neurology division is a multidisciplinary research team comprised of professionals dedicated to improving the lives of those with neurodegenerative disorders and their families. The Behavioral and Cognitive Neurology division is seeking a Clinical Translational Research Coordinator II to join the team. The coordinator will be 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. Ideally, candidates would have at least 1 year of experience.
* 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, administering neuropsychological assessments, conducting interviews regarding mental health and quality of life, tracking medication usage, etc.
* Knowledge and understanding of the implementation, coordination, management and reporting of clinical/translational research operations.
* Ability to identify and troubleshoot problems.
* Records data from 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 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.
* Demonstrates knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporates them in the conduct of research.
* Demonstrates 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.
* 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 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.
* 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.
* 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.
* 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.
* 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.
* 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.
* Actively seeks new learning opportunities, seeing learning as a part of work. Develops and achieves personal and professional goals.
Clinical Research (Novice): Can research problems that span several areas of the department. Develops and writes basic trial protocols. Knows what information is available in the company. Designs data collection forms. Has developed networking skills which assist in researching issues.
Study Design & Conduct (Novice): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.
Project Coordination (Novice): Reviews specific project related documents for completeness and accuracy and ensures project status reports are received, when due, from project managers for all approved projects. Provides administrative and logistics support for various project meetings, training, workshops and facilitated sessions. Coordinates and tracks all work requests to ensure on time project delivery. Keeps project plans updated and ensures key milestones and dependencies are understood. Responsible for record keeping for project meetings such as issues logs, gap analysis sheets, meeting minutes, making copies, team event planning and execution, team travel, on-boarding activities for contractors or consultants, set up and maintenance of project repositories.
Communication (Novice): Clearly, effectively and respectfully communicates to employees or customers.
Our Academic Enterprise is one of the nation's longest serving and most prestigious academic medical centers. Through its historic bond with Vanderbilt University and integral role in the School of Medicine, Vanderbilt Health cultivates distinguished research and educational programs to advance a clinical enterprise that provides compassionate and personalized care and support for millions of patients and family members each year.
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.
Aligning with Vanderbilt Health's Strategic Directions, the Office of Research provides shared research resources, administrative expertise and professional guidance to enable the trans-disciplinary environment and highly collaborative culture that advances discovery and training for all the research faculty, trainees, students and staff.
Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance. Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment. Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area. Team Interaction: Provides informal guidance and support to team members.
Core Capabilities :
Supporting Colleagues:- Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas.- Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.- Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences. Delivering Excellent Services:- Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.- Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.- Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness. Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.- Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.- Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation:- Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.- Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.- Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.
Work Experience :
Relevant Work Experience
Experience Level :
Less than 1 year
For a copy of the physical requirements of this position to determine if you can perform the duties with or without an accommodation or to request an accommodation, please contact VUMC Employee Relations at 615-343-4759 or email@example.com.