Skip to main content

Clin/Tran Research Coord 3

**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:**

Pediatric Infectious Disease

**Job Summary:**

JOB SUMMARY

This position is with the Halasa/Chappell Lab, jointly led by Drs Natasha Halasa and Jim Chappell, within the Division of Pediatric Infectious Diseases at Vanderbilt University Medical Center. Our laboratory research concentrates on the etiology, epidemiology, prevention, and pathobiology of infectious diseases.

This position will perform a variety of duties involved in the collection, interpretation, and documentation of data in support of clinical trials. Assists in ensuring adherence to protocols, appropriate regulations, and deadlines. Ensures quality of information received.

The individual in this position will be responsible for planning through completion and reporting, assuring that the processes, integrity and quality of the research are assessed and maintained and that the studies are conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, Vanderbilt Policy and Procedure and research protocols. This role will also serve as a resource for inquiries and maintains communication with the investigators, participants, sponsors, IRBs, DSMBs and other research related entities.

.

**REQUIREMENTS FOR SUCCESS**

+ Advanced knowledge and understanding of policies, procedures, and regulations governing human subject's research, and stipulations of sponsor contracts or requirements and incorporates them in the conduct of research.

+ Advanced knowledge and understanding of the Federal regulations and guidelines governing the protection of human subjects, e.g., FDA, OHRP, GCP/ICH , and HIPAA regulations

+ Advanced knowledge of the policies and procedures and requirements of Vanderbilt departments involved in the approval of research (IRB, grants, contracts, finance, etc.) and the ability to proficiently and compliantly maneuver though the approval processes and then assure compliance throughout the research process

+ Advanced knowledge and understanding of the management and implementation of clinical/translational research operations

**KEY RESPONSIBILITIES**

Clinical Research Compliance

+ Compliantly, accurately and proficiently prepares, processes and manages new research proposals, amendments, continuing review applications, adverse event reports, and budgets

+ 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

+ 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

Clinical Research Project Coordination

+ Understands, implements, and follows a clinical/translational study protocol and is able to conduct multiple studies independently, obtaining training or training others to safely and accurately perform or assess required protocol procedures

+ Participates in the determination of eligibility and recruits candidates for study participation. Troubleshoots trial recruitment strategies to ensure trials are completed in a timely manner through implementing effective screening and recruitment strategies and completing required documentation

+ Works collaboratively with other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, completing required participant registration in StarPanel, conducting interviews and laboratory and diagnostic studies, tracking medication usage and other protocol specific investigational procedures.

+ Effectively research complicated issues pertaining to the area of expertise. 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.

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

+ 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.

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

+ Assists in defining and using 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

Resource Utilization & Training

+ Provides training to study team members and others on project related templates and toolsets.

+ Develops methods to ensure proper team communication and obtains feedback at critical milestones and at project completion to ensure project efforts meet expectations

+ Actively identifies the need for and participates in training, education, and development activities to improve own knowledge and that of the research department and to learn about and improve research related processes (i.e., research seminars, in-services, etc)

+ Participates in research related programs, such as the Clinical/translational Research Staff Council and its activities by serving as a department representative, submitting issues or suggesting solutions, and reviewing CTRSC meeting Council information summaries, attending meetings open to research staff and by sharing information with other research personnel

+ 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

TECHNICAL CAPABILITIES

• People Management (Novice): 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 (Intermediate): 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 (Intermediate): Applies qualitative and quantitative research methods to perform preparatory, regulatory, and analytic tasking within the life cycle of a study.

• Communication (Intermediate): Clearly, effectively and respectfully communicates to employees or customers.

• Project Coordination (Intermediate): 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.

**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 :**

3 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