CLINICAL RESEARCH COORDINATOR- SECTION OF SURGICAL DISCPLINES CRU

Employer
Duke University
Location
Cardiovascular & Thoracic

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Administrative Jobs
Academic Affairs, International Programs, Research Staff & Technicians
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 tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary
Participate in or lead day to day operations of clinical research studies conducted by principal investigator(s) at Duke Health; perform a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks.

Work Performed
Research Operations

Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs). Screen participants for complex studies (e.g. ., procedural and interventional studies). Develops or helps develop SOP s. Employs and may develop strategies to maintain recruitment and retention rates and evaluate processes to identify problems. Escalates issues. Conducts and plans for visits for complex studies (e.g., procedural and interventional studies). Maintains participant level and study level documentation for all studies, including those that are complex in nature and/or require access to the Duke electronic health record (EHR). Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. Is responsible for all aspects of managing and documenting Investigational Product (IP), including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, Investigational Drug Service (IDS), and other parties as necessary. Follows protocol schema for randomization and blinding/unbinding. Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring complex procedures. May maintain study level documentation for international studies and develop resources and tools for management of international studies, and/or coordinate with other entities or offices. May prepare Federal Drug Administration (FDA) regulatory submissions in collaboration with Office of Regulatory Affairs and Quality (ORAQ), including development, submission, and maintenance of relevant documentation. Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI). Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. Leads meetings that are multidisciplinary, including those with complex objectives.

Safety and Ethics
Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. Develops consent plans and documents for participants in a variety of studies. Develops and submits documentation and information for Institutional Review Board (IRB) review. Communicates with the IRB staff and reviewers and handle issues appropriately. Identifies all adverse events (AEs), and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. Responsible for adherence to clinical research policies to ensure ethical conduct and protect vulnerable populations. Communicate to research participants the difference between clinical activities and research activities, and the risks and benefits of study participation.

Data
Enters and collects data and develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Ensures accuracy and completeness of data for all studies. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review research data security plans (RDSPs) for multiple study protocols. Maps a protocols data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.). Independently uses and implements technology to enhance productivity or process.

Scientific Concepts
Assists with or contributes to the development of funding proposals. Using scientific proposals from the PI, develops research protocols. Demonstrates a basic understanding of the elements of research study designs. Independently conducts literature searches and reviews. Contributes to the development of scientific publications or presentations and serves as an author on poster presentations or publications.

Site and Study Management
Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make feasibility recommendations. Ensures that studies are conducted in compliance with institutional requirements and other policies. Follows, and may develop or implement, protocol specific systems and documents including process flows. Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or contract research organizations (CROs). For studies with complex supplies or equipment, ensures that there are ample supplies, and that equipment is in good working order. May forecast staffing needs. Uses systems and system reports to manage research participants activities and charge routing. Prepares studies for closeout and document storage.

Leadership and professionalism
May train or oversee others in the above tasks. Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Keeps current with research updates by attending key external offerings (i. e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. May serve on committees and workgroups internal to Duke or externally in therapeutic area of research. Demonstrates resilience and is adaptive to change. Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives.

Knowledge, Skills and Abilities
Can easily use computing software and web-based applications (e.g., Microsoft Office products and internet browsers).

Minimum Qualifications
Education

Completion of an Associate's degree

Experience
Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required 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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