Jobs
>
Nashville

    research compliance coordinator - Nashville, TN, United States - Vanderbilt University Medical Center

    Vanderbilt University Medical Center
    Vanderbilt University Medical Center Nashville, TN, United States

    1 week ago

    Default job background
    Description

    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 90


    Job Summary:

    JOB SUMMARY
    Develop and coordinate mechanisms to assure compliance with human subject protection guidelines. Coordinate regulatory, data safety evaluation, and protocol development functions for on-site and multiple sites/affiliates. Provide oversight and education to staff involved in research studies. Audit investigator-initiated protocols and data and present findings to regulatory committees. Assist with study feasibility and budget development.

    .


    KEY RESPONSIBILITIES

    • Act as liaison of research activities between investigators, agencies, sponsoring companies, regulatory committees and other participants.
    • Oversees the development of protocols, the overall clinical plan, draft protocols, and coordinates the protocol review and approval process with various committees and staff.
    • Supervise staff, monitor data, and assign corrective measures for adherence to protocol and regulatory compliance.
    • Perform ongoing monitoring and evaluation of studies to assure compliance with federal and institutional regulations
    • Develop and implement auditing programs, policies, procedures, documentation and systems in accordance with Federal, State and University mandates.
    • Assist in development of research designs, amendments, and evaluations and offers direction in implementation for collection of accurate data evaluation and analysis
    • Provides advice, guidance, and problem resolution to PI on protocol design/development and data collective mechanisms.
    • Conducts data analysis and provide written research analysis for project components on a regular bases.
    • Coordinate protocol submission to the Scientific Review Committee, Radiation Safety Committee, Biosafety Committee, and IRB
    • Original proposals are created that meet institutional and FDA regulations
    • New research proposals are prepared and processed according to regulations
    • Consent forms, amendments, continuing review applications, FDA, IND applications, SAE analysis and reports are prepared and processed according to regulations
    • Obtain input from local site's IRB representative to assure consideration of local context issues in different demographic regions as applicable
    • Develop and provide training and staff development on regulatory requirements and protocol design
    • Develop and deliver training on research protocols to ensure regulatory, and University compliance
    • Provide training to physicians, nurses, professors, teachers, data collectors, regulatory coordinators, and technicians and other staff involved in research studies in an understandable manner
    • Educational needs are identified based on audits and other information; develop and deliver training as needed
    • Provide instruction on the interpretation of test results, and observations
    • Implement data safety monitoring mechanisms ensuring regulatory standards are met and coordinate reporting to Data Safety Monitoring Committee while assisting with implementation of corrective measures based on findings of audit of studies.
    • Organizes and performs random, forcause, and regulatory committeerequested audits of research studies as appropriate to ensure compliance with applicable regulations and guidelines
    • Analyze data and prepare audit reports and summaries, findings are presented to the Committee(s)
    • Ensure databases to track human subject research are implemented and maintained
    • Participate in continuous quality improvement analysis to ensure efficiency, compliance, and productivity to meet the highest standards possible. This includes training with staff development for onsite and offsite personnel as required
    • Maintain a current knowledge of Federal, State, and University laws, regulations, guidelines governing human subject research
    • Represents human subject compliance programs on various groups and committees as appropriate
    • Conducts site visits (travel required)
    • Prestudy site visits are conducted as required
    • Evaluative reports are prepared
    • Site monitoring visits are conducted and followedup to resolve identified problems
    • Files, records, case report forms, and source documents are reviewed for completeness, accuracy, and compliance; identifies deficiencies and discrepancies, and remedial training is provided as needed

    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:

    Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance.


    Problem Solving/ Complexity of work:
    Analyzes moderately complex problems using technical experience and judgment


    Breadth of Knowledge:
    Has expanded knowledge gained through experience within a professional area


    Team Interaction:
    Provides informal guidance and support to 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 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 :
    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
  • Vanderbilt University Medical Center

    clinical coordinator of quality compliance

    4 days ago

    Vanderbilt University Medical Center Nashville, TN , USA, 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 diverse individuals who come to work each day with the simple aim of changing the world. It is ...

  • Vanderbilt University Medical Center

    3843 - coordinator quality compliance clinical

    2 days ago

    Vanderbilt University Medical Center Nashville, TN , USA, 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 diverse individuals who come to work each day with the simple aim of changing the world. It is ...

  • SESAC Rights Management, Inc

    Global Tax Compliance Coordinator- SESAC

    5 days ago

    SESAC Rights Management, Inc Nashville, United States

    Job Description · Job DescriptionSESAC is looking for a Global Tax Compliance Coordinator to join our team in Nashville. In this role you will be responsible for managing assigned areas of tax operations and ensuring accuracy, quality, and effectiveness in reporting. · What You W ...

  • Elk Valley Health Services, LLC

    LPN for Private Duty Care

    6 days ago

    Elk Valley Health Services, LLC Murfreesboro, United States Full time

    We are hiring for a Pediatric Private Duty LPN in the Murfreesboro, TN area to work days, nights and weekends. Case Specific Enhanced Pay Rates are available with 6-12 shifts. We offer flexible scheduling, weekly pay and a loyalty bonus after your first 300 worked hours . · Elk V ...

  • Atrium Health

    Registered Nurse Supervisor

    2 days ago

    Atrium Health Davidson, United States Full time

    Overview · This position is Sign-On Bonus eligible. In addition to the sign-on bonus, new teammates at Atrium Health are eligible for robust benefits packages and paid time off. · Job Summary · Responsible for the direct provision of patient care and for assisting the manager wi ...

  • Adoration Home Health and Hospice

    RN Case Manager

    3 hours ago

    Adoration Home Health and Hospice Nashville, TN, United States

    Our Company: · Adoration Home Health and Hospice · Overview: · $5,000 Sign on · RNs needed in West Nashville (Bellevue), East Nashville, North Nashville (Madison/Goodlettsville), Nashville proper · Our Hospice Registered Nurse (RN) Case Managers are the heart of our organization ...

  • Elk Valley Health Services, LLC

    LPN - Private Duty Home Care

    6 days ago

    Elk Valley Health Services, LLC Hendersonville, United States Full time

    We are hiring for a Pediatric Private Duty LPN in the Hendersonville, TN area to work days, nights and weekends. Case Specific Enhanced Pay Rates are available with 6-12 shifts. We offer flexible scheduling, weekly pay and a loyalty bonus after your first 300 worked hours . · Elk ...

  • SunCrest Home Health

    RN Home Care Visits

    6 days ago

    SunCrest Home Health Hendersonville, United States

    We are hiring Home CareRNs for Visits in Hendersonville. We have PRN, part-time and full-time opportunities with weekly pay and a loyalty bonus. · At Suncrest Companion Services, a part of LHC Group, we embrace a culture of caring, belonging, and trust and enjoy the meaningful ...

  • Deaconess HomeCare

    Registered Nurse

    6 days ago

    Deaconess HomeCare Mount Juliet, United States Full time

    We are hiring for a Registered Nurse for Rutherford County. · At Deaconess HomeCare, a part of LHC Group, we embrace a culture of caring, belonging, and trust and enjoy the meaningful connections that come from it: for the whole patient, their families, each other, and the commu ...

  • TriStar Healthcare at Home

    Home Health RN Clinical Manager

    1 day ago

    TriStar Healthcare at Home Nashville, United States HHP

    Description · Introduction · Do you have the career opportunities as a(an) Home Health RN Clinical Manager you want in your current role? We invest in what matters most to nurses like you – at home, at work, and at every stage in your career. We have an exciting opportunity for ...

  • TriStar Southern Hills Medical Center

    Clinical Nurse Coordinator

    1 day ago

    TriStar Southern Hills Medical Center Nashville, United States HOS

    Description · Introduction · Do you want to be appreciated daily? Our nurses are celebrated for being on the front line, empathetic for patients. At TriStar Southern Hills Medical Center our nurses set us apart from any other healthcare provider. We are seeking a(an) Clinical Nu ...

  • SMS Holdings

    Payroll Supervisor

    3 days ago

    SMS Holdings Nashville, United States

    Summary: Plan, perform, organize, coordinate and participate in processing and auditing multiple payroll disciplines by performing the related duties and responsibilities. Providing consultation and advice to management on payroll, compliance, and emerging trends within payroll. ...

  • Nashville International Airport

    Safety Management System Coordinator

    4 days ago

    Nashville International Airport Nashville, United States

    The Safety Management Systems (SMS) Coordinator primarily conducts regulatory inspections of airport facilities (including the Air Operations Area) and identifies safety hazards under compliance with Title 14 of the Code of Federal Regulations Part 1 Management, Coordinator, Safe ...

  • Wellvana

    VP, Compliance

    1 week ago

    Wellvana Nashville, United States

    Apply · Description · Who we are: · The healthcare system isn't designed for health. We're designed to change that. We're Wellvana, and we help doctors deliver life-changing healthcare. Through our elevated value-based care programs, we're revitalizing an antiquated system that's ...

  • VEOLIA

    Environmental Manager

    6 days ago

    VEOLIA Nashville, United States

    VEOLIA is Growing in the St. Louis Area · VEOLIA is immediately seeking an Environmental Manager to join their St. Louis Area Team · Veolia is the world's leading environmental services company with over 179,000 employees globally and a 160-year history We help our customers addr ...

  • Embraer S.A.

    environment, health and safety specialist

    1 week ago

    Embraer S.A. Nashville, TN, United States

    POSITION SUMMARY · Position drives the development, organization, administration, and continuous improvement of EHS programs within the organization; including P3E. Position coordinates and conducts inspections, monitoring, sampling, testing and record-keeping as required to ensu ...

  • Centerstone

    residential counselor i

    1 week ago

    Centerstone Nashville, TN, United States

    Centerstone is among the nation's leading nonprofit behavioral health systems with thousands of employees dedicated to delivering care that changes people's lives. A dynamic, well-established organization, we offer rewarding opportunities to serve all ages in a variety of setting ...

  • Centerstone

    residential counselor i

    1 week ago

    Centerstone Nashville, TN, United States

    Centerstone is among the nation's leading nonprofit behavioral health systems with thousands of employees dedicated to delivering care that changes people's lives. A dynamic, well-established organization, we offer rewarding opportunities to serve all ages in a variety of setting ...

  • Centerstone

    residential counselor

    1 week ago

    Centerstone Nashville, TN, United States

    Centerstone is among the nation's leading nonprofit behavioral health systems with thousands of employees dedicated to delivering care that changes people's lives. A dynamic, well-established organization, we offer rewarding opportunities to serve all ages in a variety of setting ...

  • Thorndale Partners

    Payroll Coordinator

    5 days ago

    Thorndale Partners Nashville, United States

    · PAYROLL COORDINATOR DETAILS: · Title: Payroll Coordinator · Compensation: $25 - $30 / hour · Start Date: ASAP · Location: Nashville, TN · Openings: 1 · Type: Direct Hire Opportunity · REQUIREMENTS: PAYROLL COORDINATOR · 3+ years experience in recent payroll processing includin ...