School of Medicine:

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Duke Clinical and Translational Science Institute

Team Science Project Leader II

Job Title: Clinical Trials Project Leader II

Job Code: 1639

OCCUPATIONAL SUMMARY

The position will provide project management and operational leadership essential to the successful management of translational research programs and projects associated with the Duke Clinical and Translational Science Institute (CTSI) Project Office. The Project Leader will develop, coordinate, and implement research and administrative strategies essential to the successful management of translational research projects and programs. The Project Leader will work with Duke Investigators to establish the critical path needed to move their research from early discovery to impacting patient care, form project teams, bridge information across disciplines, ensure high quality data systems, identify funding opportunities, and assist faculty in identifying additional resources. The Project Leader will utilize best project management practices and knowledge of the scientific, technical, and clinical requirements for translational research projects and programs to achieve project and program goals.

WORK PERFORMED

Provide project management and operational leadership essential to the successful management of translational research programs and projects associated with the CTSI Project Office. Develop, coordinate, and implement research and administrative strategies essential to the successful management of translational research projects and programs.

General Project Management Responsibilities:

• Work collaboratively with Principal Investigators and/or other stakeholders to develop overall program/project plan. 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 and support needed to achieve their goals, identify potential obstacles, and collaboratively solve emerging problems.
• Ensure that projects are conducted in compliance with applicable regulatory requirements and institutional standards.
• Conduct regular meetings with project team, facilitate team meetings, effectively communicate relevant project information to CTSI leadership, and communicate difficult/sensitive information tactfully.
• 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.

Regulatory: Work with Investigators and Duke Regulatory to assist investigators in determining the regulatory requirements that might apply to their research; assist investigators with preparing documents for regulatory requirements, 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.

• Identify and establish agreements to perform drug optimization, synthesis, and manufacturing within Duke, with external commercial vendors, or through other collaborations.
• Identify and establish agreements to develop device prototypes and manufacture devices for preclinical and clinical trials with external commercial vendors, or through other collaborations.
• Ensure appropriate quality assurance and quality controls plans are in place.
• Provide guidance to investigators in preparing regulatory documents.

Preclinical development: Work with Investigators and Duke Regulatory to identify required studies prior to submission of an IND/IDE. Identify and help establish agreements needed to perform the required studies within Duke, with external commercial vendors, or through other collaborations (e.g. other institutions, NIH-funded resources, etc.). Work with investigators and Duke IACUC to ensure preclinical studies meet Duke IACUC requirements.

Development Plans: Organize scientific advisory boards to develop strategies for translating clinical discoveries.

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.

Program management and Program set-up: Work with stakeholders to ensure appropriate operational frameworks and compliance requirements are in place.

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.

MINIMUM HIRING SPECIFICATIONS

Education/Training

• A graduate degree in laboratory/engineering sciences related to drug or device development is required.
• Strongly prefer candidates that have completed formal project management training.

Experience/Skills

• Five years of progressively responsible experience in scientific project management in drug discovery and/ device development with a minimum of three years of experience in industry or equivalent, is required.
• Proven track record in multi-disciplinary translational research projects and capacity to build strong relationships with a variety of stakeholders including faculty members/investigators, technical/professional staff.
• Proven track record in project management, planning, prioritization and organizational skills.
• Experience in managing pre-clinical, clinical research, clinical operations, and regulatory is required. Experience in GLP, GMP, and GCP requirements is preferred.
• Experience in intellectual property considerations and commercialization development is strongly preferred.
• Experience in leading trans-disciplinary research/development projects is strongly preferred.
• Strong interpersonal, communication, and presentation skills
• Ability to manage competing and changing priorities and multiple tasks under inflexible timelines.
• Completion of a bachelor's degree plus a minimum of five years closely related research experience.[KL1]

Required Qualifications at this Level

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 three years 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) or Associates degree in Clinical Trials Research related curriculum plus a minimum of six years healthcare experience; or 2. Completion of a master's degree in Public Health, Health Administration or a related area with two years directly related clinical trials research experience; or 3. Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research; or 4. Completion of a bachelor's degree plus a minimum of five 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

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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.