Clinical/Translational Research Coordinator III - Lung Transplant

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 ofindividuals 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 uniquenessis 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. Vanderbilts mission is to advance health and wellness through preeminent programs in patient care education and research.

Organization:

Allergy Pulmonary and Critical Care Medicine

Job Summary:

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. Manages screening implements recruitment procedures consent enrollment randomization and study conduct from planning through study closeout. Performs
or implements processes to assure study-related procedures are performed as required and objectives and timelines are met. Maintains accurate and timely documentation and communication with Investigators participants IRB sponsors and other research related entities. The candidate will work on studies involving lung transplant candidates and recipients and management of organ donors.

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KEY RESPONSIBILITIES

• Knowledge and understanding of policies procedures and regulations governing human subjects 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.

• 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 data quality assurance reviews.

• Utilizes coordination skills to complete all research protocols including patient recruitment screening scheduling and organizing of study visits enrollment assessments interviews laboratory and diagnostic studies medication tracking and other protocol specific investigational procedures.

• Engages in open communication with participants by providing them with contact information and being available to answer address or refer their calls.

• Identifies and procures equipment and supplies needed to fulfill project requirements (locally and across multiple sites if required).

• Learns and then teaches phlebotomy to the study team obtains blood samples from enrolled patients as needed. Learns procedures for collection processing and storage of clinical samples.

• Records data from source documentation and/or participant interaction onto case report forms with awareness and attention to the requirements for accuracy completeness and timeliness.

• Assures research information is collected and stored in a manner that is compliant with regulations/policies and good clinical practice. Attends to query resolution in a timely manner. Participates in the development of data collection tools.

• 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.

• 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

• Responsible for study completion processes including data lock study closeout reporting 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 and assuring archival of appropriate/required documentation.

• With department administration develops and manages study budgets monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance providing reports to 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 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.

• Assesses for and implements process improvement initiatives within a clinical/translational trial and a department to assure research quality and expedient completion of recruitment timely receipt of research related payments and cost savings and expedient study reporting.

• Defines and uses metrics to drive performance improvement. Shares metrics with investigators and administrators to demonstrate areas in need of improvement and tracks metrics to demonstrate effectiveness of improved processes.

• 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 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). Actively seeks new learning opportunities seeing learning as a part of work. Develops and achieves personal and professional goals.

• The responsibilities listed are a general overview of the position and additional duties may be assigned.

TECHNICAL CAPABILITIES

• People Management: Conducts performance reviews. Effectively delegates tasks to others. Coaches subordinates on technical and interpersonal topics as well as professional development. Demonstrates team building techniques and provides leadership through personal example of good work habits open communication and effective people relationships. Involves subordinates in decisions which affect them. Demonstrates self-reliance and resourcefulness as an example to others.

• Clinical Research: Demonstrates the ability to effectively research complicated issues pertaining to the area of expertise. Presents trial protocols to a steering committee. Often employs networking to help in researching issues. Sets up study centers which includes ensuring each center has the trial materials and training site staff to trial-specific industry standards. Has used research resources maintained in outside areas.

• Study Design & Conduct: Applies qualitative and quantitative research methods to perform preparatory regulatory and analytic tasking within the life cycle of a study.

• Communication: Clearly effectively and respectfully communicates to employees or customers.

• Project Coordination: Performs project tracking and reporting relative to task completion dates dependency effects problem anticipation schedule conflicts and assignment to appropriate staff for resolution. Manages prioritization procedures for changing scope i.e. change management and project acceptance procedures. Measures progress toward goals and revises project objectives and documents applying change control procedures. Assumes responsibility as appropriate for resolving issues and seeing work through to successful completion. Provides training to project managers and others on project related templates and toolsets. Develops methods to measure customer satisfaction and obtains feedback at critical milestones and at project completion to ensure project efforts meet customer expectations.

Department Summary:

Welcome to the Division of Allergy Pulmonary and Critical Care Medicine at Vanderbilt University Medical Center.

Our mission is to:

• Deliver world-class clinical care to patients with allergic diseases pulmonary conditions and critical illness through employing a collaborative multi-disciplinary approach

• Lead in the development of cutting-edge patient-focused research that extends from basic discoveries to clinical implementation

• Provide state-of-the-art education and training to inspire and nurture the next generation of leaders in allergy and immunology pulmonary and critical care medicine and interventional pulmonology

Our Academic Enterprise is one of the nations 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 HealthsStrategic Directions the Office of Research providesshared research resourcesadministrative expertiseand professional guidance to enablethetrans-disciplinary environment and highly collaborative culture that advances discovery and training forall the research faculty trainees students and staff.

Core Accountabilities:

Organizational Impact: Independently delivers on objectives with understanding of how they impact the results of own area/team and other related teams. Problem Solving/ Complexity of work: Utilizes multiple sources of data to analyze and resolve complex problems; may take a new perspective on existing solution. Breadth of Knowledge: Has advanced knowledge within a professional area and basic knowledge across related areas. Team Interaction: Acts as a go-to resource for colleagues with less experience; may lead small project teams.

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 ones 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.

Position Qualifications:

Responsibilities:

Certifications :

Work Experience :

Relevant Work Experience

Experience Level :

3 years

Education :

Bachelors

Vanderbilt Health is committed tofosteringan environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled.