CLINICAL RESEARCH COORDINATOR

Employer
Duke University
Location
Pediatrics-Nephrology

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Administrative Jobs
Academic Affairs, 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 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.

Operations:
For complex scenarios, recognizes when all types of agreements are necessary. Directs teams to appropriate Duke offices for execution. Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs. May train others in these policies and processes. 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, IDS, and other parties, as necessary. Follows protocol schema for randomization and blinding/unblinding. May train others. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. May train others. Maintains participant level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. May train or oversee others. Employs strategies to maintain retention rates. Evaluates processes to identify problems with retention. May train or oversee others. Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. May train or oversee others. Screens participants for complex studies (e.g., procedural and interventional studies). May train or oversee others. Develops or helps develop SOPs. May train or oversee others. Collects, prepares, processes, ships, and maintains the inventory of research specimens, primarily those requiring complex procedures. May train or oversee others. Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural, and interventional studies). Provides oversight and training and lends expertise to multiple study teams. Schedules participants for research visits. Prepares necessary documents, equipment, supplies, etc. Conducts and documents non-complex visits and scripted testing or interviews.May manage participant payment. Participates in study team meetings.

Ethics:
Identifies all AEs and determines whether or not they are reportable.Collaborates with the PI to determine Attributes, including relatedness to study. May train or oversee others. Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in MaestroCare. May train or oversee others. Develops consent plans and documents for participants in a variety of studies. May train or oversee others. Develops and submits documentation and information for IRB review. Communicates with the IRBstaff and reviewers and handles issues appropriately. May train or oversee others. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. May train or oversee others.

Data:

Enters and collects data.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, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. Follows required processes, policies, and systems to ensure data security and provenance. In addition, it recognizes and reports security of physical and electronic data vulnerabilities. Learns and uses new technology when required.

Science:
Assists with simple literature searches. Under guidance, develops sections of protocols for simple studies (e.g., registries, survey studies). Demonstrates a basic understanding of the elements of research study designs. Provides some contribution to scientific publications or presentations (no authorship).

Study and Site Management:
Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits. Uses required EMR functionalities to manage participants and study visits.May train others. Records basic protocol information in clinical research management system. Collects appropriate information to determine whether the study team's participation in a specific trial is feasible. May make recommendations. For studies with simple supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. For multiple study teams, 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. May train or oversee others. Prepares studies for closeout and document storage. May train or oversee others.

Leadership:
Works with the manager to understand areas of opportunity and develop a training plan. Take training courses and apply the knowledge and skills. May also train others in the skills learned. Keeps current with research updates by attending key external departmental meetings (i.e. Research Wednesday, RPN,additional training, etc.). Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Demonstrates resilience and is adaptive to change. Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems. Communicates effectively with others, regardless of reporting relationship, to accomplish sha red work objectives.


Description of Portfolio Responsibilities: (Effort. %):


Description of Clinical Responsibilities:

Clinical responsibilities:
Type of Research:
This position will manage pediatric nephrology clinical research studies which may be complex in nature. Serve as the primary CRC to operationalize, oversee and manage Phase I to IV clinical research trials and registries involving all ages within the pediatric population and adults

Special skills:

Requires person with strong organizational skills, good time management and ability to work with patients & their families. Experience with a pediatric population is an asset but not a requirement. Good communication and leadership skills. Able to manage multiple studies.

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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