Skip to main content

This job has expired

CLINICAL TRIALS PROJECT LEADER II

Employer
Duke University
Location
Durham, NC

View more

Employment Type
Full Time
Institution Type
Four-Year Institution

Job Details


diversity employer



CLINICAL TRIALS PROJECT LEADER II
CTSI-Clinical & Translational Sci Awards

OCCUPATIONAL SUMMARY

The
position will provide project management and operational leadership essential to the successful management of CTSI Accelerator (https://www.ctsi.duke.edu) research programs and projects.The Project Leader will utilize best project management practices andknowledge of the scientific,technical, and clinical requirements to achieve project goals for translational research projects.

WORK PERFORMED

Provide project management and operational leadership essential to the success of CTSI Accelerator translational research programs and projects. Develop, coordinate, and implement research and administrative strategies essential to the successful management of translational research projects.

General Project Management Responsibilities:• Work collaboratively with Principal Investigators to develop overall program/projectplan. Provide oversight for delivery of project objectives. Serve as a resource to faculty and laboratory staff in identifying and accessing the appropriate complement of resources, collaborators and support needed to achieve their goals, identify potential obstacles, and collaboratively solve emerging problems.• Ensure projects are conducted in compliance with applicable regulatory requirements and institutional standards, including IRB and IACUC submissions, as well as the established budget, timelines,and sponsor specifications.• Schedule and facilitate regular project team meetings, effectively communicate relevant project information to CTSI leadership, and tactfully communicate difficult/sensitive information to stakeholders.• Identify operational problems, issues, obstacles, barriers, and lessons learned across the assigned projects and make recommendations to CTSI leadership regarding solutions and process/system improvements.• Ensure project documents are complete, current, and stored appropriately.• Prepare status reports and track desired metrics for inclusion in periodic progress reports.• Contribute to improvements of systems, tools, and processes used in project management practices(timeline, financial, reporting, project communication, and review standards) for translational initiatives across the CTSI.• Supports contract/legal requirements for projects, including data source use.• Ensure appropriate quality assurance and quality controls plans are in place, at an appropriate level for all projects.

Data Science/Analytics: Work with Investigators and data scientists to define data science requirements,considerations and effective implementation options utilizing novel or complex data systems and coordination of appropriate resources. Assist investigators with navigating access to data sources. Assist investigators with navigating access to quantitative research method resources.

Regulatory: Work with Investigators and Office of Regulatory Affairs and Quality (ORAQ) to assist investigators in determining the regulatory requirements that might apply to their research, consult on CMC considerations and preclinical studies required prior to submission of an IND/IDE, determine applicability of GLP and GMP requirements in anticipation of a future IND/IDE submission, anticipate regulatory and related obstacles,interface with regulatory authorities, identify appropriate resources for addressing regulatory issues, facilitate collaborative interactions between investigators and other stakeholders and institutional resources.

Drug/device/diagnostic optimization, synthesis, and manufacturing: Provide guidance to Investigators and manage outsourcing requirements.

Preclinical development: Identify and help establish agreements needed to perform the preclinical studies within Duke, with external commercial vendors, or through other collaborations (e.g. other institutions,NIH-fundedresources, etc.)

Clinical Development Plans: Organize scientific advisory boards to develop clinical strategies for translating basic science discoveries to improvement of patient care.

Licensing and Ventures: Work with Duke Investigators and the Duke Office of Licensing and Ventures (OLV) to translate academic discoveries into commercial products that benefit society, impact public health,and improve the quality of life. This includes proving guidance for submitting invention disclosure forms, preparing materials for potential licensees/investors, and providing guidance for new company creation.

Sponsored Research Proposals: Assist with development of proposals and budgets for sponsored research awards and collaborations. Assist in the identification of additional funding, collaborative, and entrepreneurial opportunities.

Subcontracts and Vendor Management: Oversee the execution and monitoring of agreements with non-Duke entities serving as subcontractors or vendors.

Financial and Compliance Reporting: Ensure appropriate legal and procurement documents are in effect. Work closely with CTSI Finance to monitor and forecast expenditures, ensure timely and accurate invoicing, and monitor receivables for projects. Work closely with the CTSI Grants Manager to ensure compliance with institutional, state, and federal policies.

Perform other related duties incidental to the work described herein.The above statements describe the general nature and level of work being performed by individuals assigned to this classification.

Preferences, Knowledge, and Skills

Five years of progressively responsible experience in scientific project management in drug discovery and development. • High capacity to build strong relationships with a variety of stakeholders including faculty members/investigators, technical/professional staff and biotechnology interests. • Proven track record in project management, planning, prioritization and organizational skills. • Proven track record in drug development, pre-clinical, clinical research, clinical operations, data science/analytics and/or regulatory is required. Experience in GLP, GMP and GCP is desired. • Experience in intellectual property considerations and commercialization development is strongly preferred. • Strong interpersonal, communication, and presentation skills. • Ability to manage competing and changing priorities and multiple tasks under inflexible timelines. • Strongly prefer candidates with experience in data science/analytics strategy and management. • Strongly prefer candidates with grant writing experience. • An individual who will be successful in this position should bring refined hands-on laboratory experience, direct experience developing in vitro and in vivo models for drug development, direct experience in and a good working knowledge of early translation into the clinical setting, good working knowledge of data science/analytics strategy and entrepreneurial experience in start-up mode.

Requisition Number
401481653

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1639 CLINICAL TRIALS PROJECT LEADER II

Job Family Level
78

Exempt/Non-Exempt
Exempt

Full Time / Part Time
FULL TIME

Regular / Temporary
Regular

Shift
First/Day

Minimum Qualifications
.
Duke University 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 essential job 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.


Education

Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant(PA) or Pharmacist plus three years of healthcare experience; or one ofthe following equivalents:1. Completion of an allied health degree (e.g., RespiratoryTherapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus aminimum of six years healthcare experience; or2. Completion of a master's degree in Public Health, HealthAdministration or a related area with two years directly relatedclinical trials research experience; or3. Completion of a bachelor's degree plus a minimum of four yearsdirectly related experience in clinical trials research; or4. Completion of a bachelor's degree plus a minimum of five yearsclosely 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

Auto req ID

104464BR

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

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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.

PI106598930

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.”

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert