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 diverse 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 recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and 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.

Organization:

VICC - Clinical Trials 40

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. This role requires high volume regulatory work.

Strongly preferred skills:
OnCore
CCRP certification
Veeva SiteVault experience

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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.

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.

Core Accountabilities:

Organizational Impact: Delivers projects/assignments that have a direct impact on goals/objectives of the unit/department that the job is in. Problem Solving/ Complexity of work: Conducts extensive analysis of situations or data to resolve numerous, complex issues; may involve the input/work of others. Breadth of Knowledge: Has in-depth level of knowledge within a professional area and working knowledge of other areas. Team Interaction: May lead mid-sized projects; coaches and guides 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 Service: - 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 :

LIC-Licensed Discipline Specific - Licensure-Others

Work Experience :

Relevant Work Experience

Experience Level :

5 years

Education :

Bachelor's

Vanderbilt Health recognizes that diversity is essential for excellence and innovation. We are committed to an inclusive environment where everyone has the chance to thrive and to the principles of equal opportunity and affirmative action. EOE/AA/Women/Minority/Vets/Disabled