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 60

Job Summary:

The Scientific Review Administrator manages the scientific review committee, correcting minutes from review committee meetings. This individual serves as a team leader for other SRA's by providing guidance and assistance to investigators and their teams by providing assistance with the development of their proposal applications. Identifies training and development for staff. Defines work assignments and performance expectations for team members. Encourage self development and learning through regular, immediate feedback. Collaborate with internal and external customers to develop and evaluate services for the improvement of human research protection program using standard organizational-wide guidelines.

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KEY RESPONSIBILITIES
* Research proposals, applications for funding support, amendments, extension requests, and other reviews.
* Independently perform a comprehensive pre-review of investigator submitted protocols to ensure cohesive scientific flow and to confirm there are not any gaps or missing sections that are relevant to the committee review of the protocols. Verifies consistency of protocol with application, contract, etc.
* Assist investigator/study coordinator in the development for the application, protocol, consent forms, etc. Ensures investigator/study coordinator understand how to develop various aspect of clinical research applications, etc.
* Perform as Team Leader for the Scientific Review Analysts. Serve as a team member on various committees to ensure staff are advising researchers appropriately regarding VUMC interpretation of laws, etc. Proactively communicate complex and comprehensive clinical and scientific information to the team members, committee members, etc.
* Independently determine when submitted protocols, etc., are complete and of sufficient quality to route for pre-review.
* Provide guidance and assistance to investigators and their teams by providing assistance with the development of their proposal applications.
* Determine to whom proposals should be routed for pre-review and assign primary/secondary SRC reviewers. Coordinate pre-review with other experts in the areas of budgets, biostatistics, informatics, nursing, and other scientists as relevant. Work with the research team to ensure areas of concern and questions identified by experts during the pre-review have been addressed and are adequate for SRC review prior to routing to the SRC.
* Ensure expedited applications are complete and scientifically meet the requirements for expedited review. Make recommendation to SRC Chairperson regarding scientific merit. Assist the SRC Chairperson in expedited review of proposals that meet the criteria for expedited review. After pre-review, independently determine whether the proposal meets the criteria to be routed to the SRC Chairperson for expedited review or requires full SRC review. If full committee, place on the next available committee agenda.
* As team leader provides oversight of to ensure accuracy of documentation of all activities of the SRC. Ensure the integrity of SRC data, review data, develop, maintain and review reports. Assist with fulfilling reporting requirements of the funding agency.
* Review and edit provisional letters and approval letters generated as a result of SRC meetings prior to SRC Chairman review/sign off.
* Central resource for the research community.
* Will provide expertise and guidance on various issues, goals, regulatory requirements, development strategies, ethical considerations as well as institutional and foundation policies as related to the SRC, as well as other areas of VUMC.
* Represents the department at institutional activities regarding culture and regulatory issues as it relates to research in the community.
* Establish and maintain good communication with investigators, research support staff, students, etc.
* Participate as a major component of the team to establish new learning opportunities for a range of individuals in the research arena.
* Demonstrates ability to understand the science of research design and protocol development to actively lead institutional activities and regulatory issues related to research.
* Monitor and analyze new legislation, regulations, guidance documentation and program initiatives to stay on top of current trends and changes in the research community.
* Establish and maintain communications with institutional officials, institutional committees, investigators, research staff, representatives of professional organizations, participant advocates, etc.
* Effectively applies analytical/problem solving skills and continuous quality improvement (CQI) tools and methods in daily work activities.
* Provides supervisor and upper management with suggestions for improving processes within the department.
* Uses innovative thinking when developing alternative solutions.
* Attend institutional CQI courses.
* Scientific Review Committee (SRC) meetings.
* Proficient in development and review of all documents processed for the SRC to ensure compliance with departmental, institutional, and agency policies and procedures. These documents include award statements, annual review requests, requests for additional documentation, any special call for applications, etc.
* Facilitate the flow of SRC meetings to ensure effective utilization of time and limited interruptions.
* Ensure appropriate audio/visual equipment is available and working for all SRC meetings.
* Participates in the development of SRC minutes, ensuring they accurately reflect discussions and decision made during the meetings. Routes minutes for review and approval of the SRC Chairman/Committee. Makes modifications to minutes as suggested by the SRC Chairman/Committee.
* Review agenda for SRC meetings including prioritizing and assigning reviews before the meetings based on areas of expertise.
* Training for research personnel including investigators, research coordinators, research nurses, etc.
* Identify training needs for researchers and their staff.
* Assist in creating online training tools
* Work in conjunction with the RSS group on establishing training classes for "how to's
* As a member of the department will assist with developing training manuals for various services, procedures, etc.
* Demonstrate willingness to learn new skills and continue to work with supervisor to set developmental goals for self and program.
* Develops and implements quality assurance and regulatory plans/projects for the VU research community to assure compliance with all applicable regulatory requirements.
* SRC documentation.
* Independently and proficiently develop agenda packets for SRC meetings. This includes development of agenda, sign-in document, secret scoring document for each reviewer to rank projects that are reviewed and approved at the SRC meetings, etc.
* Prepare approval letters, denial letters, and requests for additional information for all protocols, amendments, extensions, requests for progress reports, requests for publications, etc.
* Assist in development of a quarterly report of submissions and SRC operations.
* Demonstrates facilitative leadership to foster productive teamwork through coaching and mentoring.
* Communicates and models values and mission of VUMC.
* Exhibits personal integrity and respect for others.
* Treats all team members as unique individuals with valuable resources and skills that enhance the team.
* Collaborates with internal customers to assist in developing departmental, team, and individual goals through ongoing training and supplemental support.
* Accepts responsibility for improvement of one's performance through recognition of strengths and weaknesses, participation in professional development activities and positive input in team growth.
* Demonstrates a positive attitude in response to work environment stressors, problem resolution, constructive feedback, and suggestions for improvements.
* Takes responsibility for mistakes or bad decisions and learns from mistakes.
* Coordinates and supervises other team member's performance for all activities, before, during and after committee meetings.
* Establishes and promotes collaborative relationships with investigators and key study personnel focusing on listening skills and education.
* Actively facilitates conflict resolution. Escalates as appropriate.
* Confirms accuracy and content of materials for meetings.
* Informs the Scientific Review Committee Director and the Program Director of potential compliance issues or concerns.
* Defines work assignments and performance expectations for team members. Performs evaluations and re-evaluations as necessary.
* Encourage self development and learning through regular, immediate feedback.
* Assess and identify deficiencies in workflow. Present findings to departmental leadership for further review and possible implementation.
* Identifies, establishes, and evaluates quality improvement (QI) standards, programs, procedures within the department.
* Actively participate in establishing and evaluating quality improvement standards for the department.
* Actively seek customer feedback on services and incorporate suggestions to improve processes.
* Create internal audit tools. Conduct complex internal audits. Present findings to department's operations committee.
* Provides continued assistance, consultation and education to research personnel regarding quality assurance, data discrepancies, and deviations from protocol criteria.
* Assist in the development of standard of operations for the department.
* Collaborate with internal and external customers to develop and evaluate services for the improvement of human research protection program using standard organizational-wide guidelines.
* Confers with research coordinator/investigator regarding the development of protocols and study budgets to ensure accuracy of capturing all study costs.
* Works with Research Finance officials to ensure compliance with Medicare, etc. guidelines for invoicing, etc.
* Analyzes cost estimates and budget requests. Assist investigator in determining appropriate cost escalation, etc.

TECHNICAL CAPABILITIES

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: 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 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.

Position Qualifications:

Responsibilities:

Certifications :

Work Experience :

Relevant Work Experience

Experience Level :

5 years

Education :

Associate'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