CLINICAL TRIALS COORDINATOR I, DCRI Gov't & Networks*

Employer
Duke University
Location
DCRI - Government Operations

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Employment Type
Full Time
Institution Type
Four-Year Institution

Job Details

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Position Summary:

The Government Trials & Network Trial Coordinator (CTC) is responsible for performing and implementing a variety of independent duties involved in the organization, training, oversight, documentation, conduct and clinical data review for clinical trials that are being managed by Duke Clinical Research Institute (DCRI). This work is done for phase I, II, III, IV, trials and other clinical research endeavors conducted by DCRI.

Most DCRI positions can be done remotely for candidates who live in the following states: NC, CA, FL, GA, MD, NY, SC, TN, TX, VA, and District of Columbia (DC), Arizona, Hawaii, Illinois, Montana.

Primary Responsibilities and Tasks:

1. Project/Trial Organization

  • Draft/Create Project‐Specific Plans/Documents for trial activities:
  • Feasibility Form
  • CTMS Setup Form
  • Data Entry Guidelines (DEGs)
  • Manual of Operations (MOO/MOP)
  • In‐service Manual
  • Remote Monitoring Plan
  • Regulatory document collection process
  • Custom Reports
  • Compile and review site feasibility information and provide site recommendations/feedback to trial supervisor
  • Provide content to Clinical Monitoring Plan (CMP).
  • Maintain Remote Monitoring Plan and make changes as needed.
  • 2. Project/Trial Training

    • Create and deliver trainings for Project‐Specific Plans/Documents by utilizing a variety of applications (Word, Excel, PowerPoint)
    • Provide trial training and guidance to research staff (internal and external) for conducting the study in accordance with the following:
    • Protocol
    • SOPs
    • Trial specific procedures
    • Applicable regulations

    3. Site Management Oversight

    • Serve as trial supervisor, mentor and coach for all assigned Clinical Trials Associates (CTAs) and provide input into all assigned CTAs evaluations
    • Routinely review available metrics reports, data entry and inspect study files to ensure completeness and accuracy. Take action as appropriate by providing feedback/training if required
    • Oversee and ensure distribution of appropriate forms, supplies, equipment, laboratory samples, and investigational product are received by the site according to the established trial timeline
    • Communicate with laboratories or investigators regarding laboratory findings
    • Direct the process for collection, labeling, storage, or shipment of specimens
    • Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies

    4. Project/Trial Documentation

    • Serve as Clinical Trial Management System (CTMS) user expert (Super User) by being able to perform, explain and train on the following activities:
    • DEG
    • Clinical Trial Management System Request Form (CTMSR)
    • Site Creation
    • Global Data Requests
    • Site Status
    • Activity Plans
    • Milestone Tracking
    • Document attachment (Training/Safety Letters/other)
    • Account Affiliations
    • Conversation Log
    • Available reports
    • Confirmation/Follow‐Up Letters
  • Oversee and review CTA CTMS data entry and Trial Master File (TMF) filing is in compliance with DEG and Standard Operating Procedures (SOPs)
  • Supervise the CTA review of the following regulatory documents:
  • Protocol Signature Page
  • Form FDA 1572
  • Principal Investigator Curriculum Vitae (CV) and Medical License
  • Principal Investigator Financial Disclosure
  • Sub‐investigator Curriculum Vitae (CV) and Medical License
  • Sub‐investigator(s) Financial Disclosure(s)
  • IRB Approval of Protocol and any Amendment(s)
  • IRB Approval of Informed Consent Form
  • IRB Approval of Assent Form
  • IRB Approval of Translation of ICF & Assent Form
  • IRB Approval of Health Insurance Portability and Accountability Act (HIPAA)
  • Investigator’s Brochure (IB) IRB Membership Roster or FWA number
  • 5. Clinical Trial Conduct

    • Interpret protocols and advise research staff (internal and external) on appropriate conduct of the study in accordance with the protocol, SOPs, trial specific procedures and applicable regulations

    • Identify protocol problems, inform trial supervisor of problems, or assist in problem resolution efforts such as protocol revisions

    • Monitor all trial activities/communications to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.

    • Identify action items and discuss with appropriate research staff. Communicate routine and unusual findings to trial supervisor

    • Regularly review trial and site status information and enter updates into required systems to maintain accurate, current reports.

    • Follow established guidelines in the collection of clinical data and/or administration of clinical trials

    • Confer with site coordinators and physicians to explain protocol and elicit compliance with regulations; ensure compliance with Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.

    6. Clinical Data Review

    • Perform in‐house monitoring activities by independently reviewing and evaluating the following:
    • Informed Consent Forms (ICFs)
    • Source documentation
    • Case Report Forms (CRFs)
    • Adverse Events (AEs)
    • Serious Adverse Events (SAEs)
    • Laboratory results
  • Uses knowledge of protocol to interpret data and work with other functional groups to resolve clinical data issues
  • Routinely use data management reports/system to identify/resolve discrepancies in the clinical data
  • 7. Accountability

    • Identifies and follows through on opportunities for self-improvement.

    Education/Training

    Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician’s Assistant (PA) or Pharmacist plus one year of healthcare experience, or one of the following equivalents:

    1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) plus a minimum of three years healthcare experience; or

    2. Completion of a master’s degree in Public Health, Health Administration or a related area with no additional experience; or

    3. Completion of a bachelor’s degree plus a minimum of one year directly related experience in clinical trials research; or

    4. Completion of a bachelor’s degree plus a minimum of two years closely related research experience.

    **State of North Carolina license may be required. ** EXPERIENCE

    None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

    Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

    Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

    Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

    Organization

    Read our Diversity Profile History

    Duke University was created in 1924 by James Buchanan Duke as a memorial to his father, Washington Duke. The Dukes, a Durham family that built a worldwide financial empire in the manufacture of tobacco products and developed electricity production in the Carolinas, long had been interested in Trinity College. Trinity traced its roots to 1838 in nearby Randolph County when local Methodist and Quaker communities opened Union Institute. The school, then named Trinity College, moved to Durham in 1892, where Benjamin Newton Duke served as a primary benefactor and link with the Duke family until his death in 1929. In December 1924, the provisions of indenture by Benjamin’s brother, James B. Duke, created the family philanthropic foundation, The Duke Endowment, which provided for the expansion of Trinity College into Duke University.Duke Campus

    As a result of the Duke gift, Trinity underwent both physical and academic expansion. The original Durham campus became known as East Campus when it was rebuilt in stately Georgian architecture. West Campus, Gothic in style and dominated by the soaring 210-foot tower of Duke Chapel, opened in 1930. East Campus served as home of the Woman's College of Duke University until 1972, when the men's and women's undergraduate colleges merged. Both men and women undergraduates now enroll in either the Trinity College of Arts & Sciences or the Pratt School of Engineering. In 1995, East Campus became the home for all first-year students.

    Duke maintains a historic affiliation with the United Methodist Church.

    Home of the Blue Devils, Duke University has about 13,000 undergraduate and graduate students and a world-class faculty helping to expand the frontiers of knowledge. The university has a strong commitment to applying knowledge in service to society, both near its North Carolina campus and around the world.

    Mission Statement

    Duke Science"James B. Duke's founding Indenture of Duke University directed the members of the University to 'provide real leadership in the educational world' by choosing individuals of 'outstanding character, ability, and vision' to serve as its officers, trustees and faculty; by carefully selecting students of 'character, determination and application;' and by pursuing those areas of teaching and scholarship that would 'most help to develop our resources, increase our wisdom, and promote human happiness.'

    “To these ends, the mission of Duke University is to provide a superior liberal education to undergraduate students, attending not only to their intellectual growth but also to their development as adults committed to high ethical standards and full participation as leaders in their communities; to prepare future members of the learned professions for lives of skilled and ethical service by providing excellent graduate and professional education; to advance the frontiers of knowledge and contribute boldly to the international community of scholarship; to promote an intellectual environment built on a commitment to free and open inquiry; to help those who suffer, cure disease, and promote health, through sophisticated medical research and thoughtful patient care; to provide wide ranging educational opportunities, on and beyond our campuses, for traditional students, active professionals and life-long learners using the power of information technologies; and to promote a deep appreciation for the range of human difference and potential, a sense of the obligations and rewards of citizenship, and a commitment to learning, freedom and truth.Duke Meeting

     “By pursuing these objectives with vision and integrity, Duke University seeks to engage the mind, elevate the spirit, and stimulate the best effort of all who are associated with the University; to contribute in diverse ways to the local community, the state, the nation and the world; and to attain and maintain a place of real leadership in all that we do.”

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