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CLINICAL TRIALS PROJECT LEADER II- DCRI - CTTI

Job description


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CLINICAL TRIALS PROJECT LEADER II- DCRI - CTTI
DCRI - CTTI

Occupational Summary:
Develop, coordinate, and implement research and administrative strategies essential to the successful design, management, and completion of research projects on clinical trial methodologies conducted by the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by the US Food and Drug Administration and Duke University, and interactions with members about CTTI activities.

Work Performed
  • In collaboration with executive-level Team Leader(s), assist in the development of project plans for concepts approved by the Executive Committee
  • Develop task lists, list of skills needed in team members, and estimated human and financial resources needed for new project plans
  • On assigned research projects, serve as the central person responsible for facilitating the activities of a #virtual# project team composed of individuals from a variety of sectors, such as FDA, industry (drug, device, biologic, or CROs [clinical research organizations]), investigator groups, NIH, professional societies, and patient representatives # Serve as an operational partner to team leader(s) who will provide vision and context for the specific project; define realistic project timelines and milestones
  • Work with the team leader and members to develop, coordinate, and implement research strategies to ensure successful management of each project # Coordinate and manage all aspects of selected CTTI projects, ensuring adherence to project timeline, budget, and deliverables
  • Utilize available tools, such as Microsoft Project, to assist in planning and structuring research activities and processes
  • Notify the Executive Director of #out of scope# activities that may need to be undertaken on a project and the extent to which they will increase the financial or human resources required and/or impact the timeline # Notify the Executive Director if there is modification of project timeline in absence of #out of scope# activities
  • Assist in the identification and solicitation of in-kind and financial resources required to complete a project
  • Maintain awareness of various stakeholder perspectives applicable to a project and identify strategies to engage multiple stakeholders in the project
  • Facilitate and guide communications/interactions among project team members, the Steering Committee, Executive Committee, and the Executive Director
  • Work with team members to submit protocols for IRB review, if applicable, and maintain currency of all regulatory requirements for all projects
  • On projects for which the project manager is responsible, manage subcontracts, including review and approval of submitted invoices and tracking sub contractors adherence to timeline and deliverables
  • Assist in the writing/preparation of abstracts, manuscripts, and presentations
  • Prepare a variety of narrative and analytic reports, documents, and correspondence for CTTI leadership, team leader(s), and team members regarding project status; recommend corrective action as necessary
  • Develop and implement strategies for dissemination of project results and associated CTTI recommendations
  • Participate in any enterprise-wide project management system adopted by CTTI
  • Field external inquiries about CTTI membership
  • Perform other related duties incidental to the work described herein. Desirable Behaviors
  • Appropriately solicits advice and guidance in areas outside of his/her expertise # Exhibits ability to manage a heavy workload by prioritizing appropriately
  • Actively promotes a timely resolution of all operational issues and problems and ensures that appropriate individuals are included in the discussion
  • Discusses problems immediately before they have gotten out of control
  • Considers impact of decisions on project timelines, quality, and costs
  • Recognizes issues that would put a project at risk and alerts the Senior Clinical Project Manager
  • Listens well and is open to suggestions from team members
  • Demonstrates clear and concise verbal and written communication skills for both internal and external audiences
  • Encourages open and honest communication # Demonstrates the ability to step back from details and see the bigger picture
  • Accepts responsibility for outcomes of work even if task was delegated
  • Admits mistakes and refocuses efforts
  • Demonstrates initiative to deal with unfamiliar situations
  • Demonstrates a #can do# attitude Minimum Hiring Specifications

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 2 years experience managing multi- center clinical trials, or one of the following equivalents:
1. Completion of a master#s degree in Business Administration, Health Administration, Public Health or a related area with 3 years directly-related experience managing multi-center clinical trials; or
2. Completion of a bachelor#s degree plus a minimum of 5 years directly related experience managing multi-center clinical trials
3. Completion of a bachelor#s degree plus a minimum of 6 years closely related research experience OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION OR EXPEREINCE **State of North Carolina license may be required** PREFERRED MANAGEMENT EXPERIENCE: Successful candidates generally have a minimum of 3 years of experience in the following areas: # Clinical research management: Operational understanding of a broad set of research processes and guidelines, including study design, methods, data, and relevant FDA and HHS regulations and guidelines # Multidisciplinary(multiple levels of same type or cross-functional) team management: Experience delegating tasks # Financial management: Operational understanding of the common components of a budget QUALITIES Listening skills Strong communication skills (oral and written) Political sensitivity Respectfulness Teamwork SKILLS Budget projections Writing Skills Presentation Skills Capability of conducting literature searches Software knowledge: Microsoft Windows Microsoft Word Microsoft Excel Microsoft PowerPoint Microsoft Project or equivalent project management software Microsoft Access, desirable

Requisition Number
401516247

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


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 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
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.

Auto req ID

106763BR

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.

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Job No:
Posted: 11/8/2018
Application Due: 1/7/2019
Work Type:
Salary: