Clin/Tran Research Coord IV, Pediatric Cardiology
Montgomery College, Nashville, TN, United States
**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. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness 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.**Organization:**Pediatric Cardiology**Job Summary:**JOB SUMMARY
Provides leadership in coordinating the approval processes and conducting 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..KEY RESPONSIBILITIES• Serves as a role model, mentor, supervisor and consultant across teams and departments to provide expertise and share knowledge. Responsible for training and onboarding new and existing staff within the department and facilitates study and project related team meetings.• Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently. (Able to identify when training is needed to safely and accurately perform or assess required procedures. Prepares, provides and/or participates in needed training). Problem solves when needed• Assists in identifying eligibility criteria for a protocol and assessing feasibility of recruiting and enrolling adequate populations locally and at participating sites. Monitors recruitment across projects, implementing process improvement to assure projects are completed in a timely manner• 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. Assists in determining data variables, in designing data dictionaries, and in developing data collection tools and databases and quality assurance processes.• Oversees the management of research samples. Receives and tracks receipt and status of study specimens from multiple sites. 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. Develops study specific standard operating procedures and tracking tools for specimen processing and handling. Develops systems and procedures for the processing and management of research samples. Ensures that all program staff have completed appropriate training as required• Digests complex clinical/translational information to determine if documentation is accurate and, complete. Understands standard of care versus research and its application in billing compliance. Participates in budget and contract negotiation and facilitates interactions between sponsors and institutional departments.• Responsible for project completion processes including timely study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing periodic quality checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice• Independently manages operational issues for large single and multi-center clinical/translational trials, including interacting with participating sites in the management of coordinating center activities, training, budget and invoicing, reporting to investigators, department administration and funding agencies• Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, representatives of professional organizations, participant advocates, and members of 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• Defines and uses metrics to drive performance improvement. Shares metrics with investigators and superiors to demonstrate areas in need of improvement and track metrics to demonstrate effectiveness of improved processes• The responsibilities listed are a general overview of the position and additional duties may be assigned.TECHNICAL CAPABILITIES• Communication (Advanced): Clearly, effectively and respectfully communicates to employees or customers.• Project Coordination (Advanced): 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.• Study Design & Conduct (Advanced): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.• Clinical Research (Advanced): Knows what job-related resources are available throughout the company. Prepares final reports and manuscripts for publication. Coordinates with an ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects. Can quickly sort through volumes of information to get the right answer. Has a working knowledge of most of the department's information resources. Is a respected clinical research analyst within the company.• People Management (Intermediate): Successfully resolves conflicts and disciplinary problems. Provides counseling and career development planning to subordinates. Constructively gives timely positive and negative feedback, confronting individual performance problems in a professional and sensitive manner. Aware of the values, abilities and needs of others. Demonstrates the ability to create a positive work climate, establishing a feeling of partnership and empowering others. Has set, coached and assessed the assignment objectives of subordinates. Practices and rewards behaviors supportive of company values.**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., the Office of Research provides shared research resources, administrative expertise and professional
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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. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness 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.**Organization:**Pediatric Cardiology**Job Summary:**JOB SUMMARY
Provides leadership in coordinating the approval processes and conducting 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..KEY RESPONSIBILITIES• Serves as a role model, mentor, supervisor and consultant across teams and departments to provide expertise and share knowledge. Responsible for training and onboarding new and existing staff within the department and facilitates study and project related team meetings.• Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently. (Able to identify when training is needed to safely and accurately perform or assess required procedures. Prepares, provides and/or participates in needed training). Problem solves when needed• Assists in identifying eligibility criteria for a protocol and assessing feasibility of recruiting and enrolling adequate populations locally and at participating sites. Monitors recruitment across projects, implementing process improvement to assure projects are completed in a timely manner• 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. Assists in determining data variables, in designing data dictionaries, and in developing data collection tools and databases and quality assurance processes.• Oversees the management of research samples. Receives and tracks receipt and status of study specimens from multiple sites. 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. Develops study specific standard operating procedures and tracking tools for specimen processing and handling. Develops systems and procedures for the processing and management of research samples. Ensures that all program staff have completed appropriate training as required• Digests complex clinical/translational information to determine if documentation is accurate and, complete. Understands standard of care versus research and its application in billing compliance. Participates in budget and contract negotiation and facilitates interactions between sponsors and institutional departments.• Responsible for project completion processes including timely study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing periodic quality checks of clinical/translational data that has been entered on the case report forms (paper or electronic) or in reports and assuring archival of appropriate/required documentation. Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice• Independently manages operational issues for large single and multi-center clinical/translational trials, including interacting with participating sites in the management of coordinating center activities, training, budget and invoicing, reporting to investigators, department administration and funding agencies• Serves as an advocate for human subjects by establishing and maintaining communication with Investigators, research staff, representatives of professional organizations, participant advocates, and members of 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• Defines and uses metrics to drive performance improvement. Shares metrics with investigators and superiors to demonstrate areas in need of improvement and track metrics to demonstrate effectiveness of improved processes• The responsibilities listed are a general overview of the position and additional duties may be assigned.TECHNICAL CAPABILITIES• Communication (Advanced): Clearly, effectively and respectfully communicates to employees or customers.• Project Coordination (Advanced): 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.• Study Design & Conduct (Advanced): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.• Clinical Research (Advanced): Knows what job-related resources are available throughout the company. Prepares final reports and manuscripts for publication. Coordinates with an ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects. Can quickly sort through volumes of information to get the right answer. Has a working knowledge of most of the department's information resources. Is a respected clinical research analyst within the company.• People Management (Intermediate): Successfully resolves conflicts and disciplinary problems. Provides counseling and career development planning to subordinates. Constructively gives timely positive and negative feedback, confronting individual performance problems in a professional and sensitive manner. Aware of the values, abilities and needs of others. Demonstrates the ability to create a positive work climate, establishing a feeling of partnership and empowering others. Has set, coached and assessed the assignment objectives of subordinates. Practices and rewards behaviors supportive of company values.**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., the Office of Research provides shared research resources, administrative expertise and professional
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