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CLINICAL RESEARCH COORDINATOR, SR

Employer
Duke University
Location
Population Health Sciences

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

Oversee the day-to-day operations of multiple studies, including a federally-funded grant examining the quality of life for persons living with Alzheimer’s disease and Alzheimer’s disease-related dementias. Performa variety of complex duties involved in the collection, documentation, analysis, and dissemination of clinical research data. Oversee the development and maintenance of task orders, budgets, and contracts related to the Department of Population Health Sciences’ participation in the FDA Sentinel Initiative.

Operations

Independently prepare or oversee the submission of data use agreements, material transfer agreements and/or other documentation required to access, collect, or analyze data. Monitor or lead procedures for recruitment, screening, assessments, and participant retention. Monitor enrollment goals and recruitment tracking. Lead or participate in the development of interview guides, qualitative data coding/codebooks, and qualitative content analyses. Facilitate and organize the development of stakeholder and engagement panels to ensure the collection of high-quality, patient-centered data.

Develop protocols, operational plans, and timelines for multiple studies. Schedule and lead team meetings; keep and circulate meeting minutes; and facilitate communication between research teams. Maintain decision logs and inform teams of timelines and progress on benchmarks and milestones. Serves an expert resource regarding regulatory and institutional policies and processes. Independently navigate conversations with agencies, vendors, and study teams to develop or obtain the required documentation for compliance with local or domestic regulations.

Ethics

Prepare and submit IRB protocols and research data security plans. Serve as an expertresourcewith regard to conducting and documenting consent, including liaisingwith and being knowledgeable about other resources at Duke. Serve as expertresource to study teams, as they design studies, so they include specificsafeguards to ensure ethical conduct and protect vulnerable populations.

Data

Select datacapture methods anddiscuss advantages and disadvantages of each. Conduct patientinterviewsand participate in the development of interview guides. Lead oroversee the development of qualitative coding guides. Recognize trends, andrecommend strategies to improve processes. Serve as a data corrections, queries, and quality assurance expert resource; including liaising with andbeing knowledgeable about other related resources at Duke. Assist study teams in developing protocols that include strategies and processes to ensure data security and provenance. Map data flow and predict areas of vulnerability in the data flow plan.

Science

Develop portions of funding proposals and grants. Assess and determine solutions for operational shortcomings of proposals. Independently review articles, synthesize the literature, and use to assist in the development of manuscripts or grant proposals. Independently develop protocols for investigator-initiated studies. Use expertise in research design to provide significant contribution to protocols or research proposals. Contribute to accepted, peer-reviewed publications or conference presentations, as appropriate. Participate in the development of user guides and best practice guides.

Study and Financial Management

Use and oversee usage of systems and system reports to manage research participants' activities. Oversee management of resources (staff, supplies, equipment). Ensure that studies are conducted in compliance with institutional requirements and other policies. Develop and oversee processes to determine participation in clinical research. Make feasibility recommendations. Develop and implement closeout procedures. Assist with or lead investigations and communications related to funding opportunities. Assist with or lead the development of task orders, budgets, and contracts. Serve as resource to help monitor, verify, and reconcile expenditure of budgeted funds, as appropriate. Recognize allowable expenses based on financial guidelines. Coordinate with others to monitor and report on financial program milestones. Serve as a liaison with sponsors, subcontractors, and/or vendors.

Leadership

Encourage staff to take part in professional development opportunities. Participate in committees and workgroups. Employ interpersonal skills to get work done efficiently. Recognize and escalate organizational issues that could be optimized to improve research process. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems.

Type of Research

The DataShare in the Department of Population Health Sciences facilitates the conduct of research using administrative healthcare claims data, commercial claims data, electronic health records, survey data, biospecimens, and clinical registries. These data are used to answer research questions in: health services research and policy, health disparities research, and health outcomes research. The DataShare supports research studies lead by faculty internal and external to the Department of Population Health Sciences.

Special skills
Detail-oriented, strong written and verbal communication skills, and highly organized to provide operational oversight to multiple retrospective and prospective studies across multiple study teams and multiple PIs. The most qualified candidates will also possess a familiarity with data contracts and agreements, in addition to experience with recruitment and screening for qualitative research. A strong foundation in team science is requirement of this position. The candidate must be able to multi-task effectively; is self-motivated and is action-oriented with a strong sense of accountability and responsibility to complete tasks accurately, efficiently, and on time. The candidate in this position is required to have strong interpersonal skills to work with individuals across and above their research role.

Minimum Qualifications

Education

Work requires an Associate's degree

Experience

Work requires a minimum of six years of 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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