CLINICAL TRIALS PROJECT LEADER I, DCRI

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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Pharmacometrics

Clinical Trials Project Leader I

Position Summary

Develop, coordinate, and implement research and administrative strategies essential to the successful management of phase I, II, III, and IV clinical trials research projects as well as registries and observational studies conducted by principal investigator(s) at Duke Clinical Research Institute (DCRI); perform a variety of duties involved in the organization, documentation and compilation of clinical research data.

** NOTE: This position may have an opportunity to work remotely. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut, Indiana, Michigan, Maine, Ohio and New Hampshire.

Primary Responsibilities and Tasks

Project Management:

a) Develops, coordinates, and implements strategies and processes essential to the successful management of clinical research projects.

b) Contributes to protocol design and modification.

c) Defines and executes realistic project timelines and milestones from contract negotiations to close-out.

d) Develops and maintains project history, operations documentation, and files.

e) Exhibits ability to manage a heavy workload by prioritizing appropriately.

f) Exhibits operational understanding of scientific premise of study, regulatory requirements, contractual requirements, technical issues, standard operating procedures, and common research processes and guidelines, including designs, methods, and data.

Problem Resolution:

a) Actively promotes a timely resolution of all operational issues and problems and ensures that appropriate personnel are included in the discussion.

b) Considers impact of decisions on project timelines, quality, and costs.

c) Consults with other project leaders, and others as appropriate, on resolution to operational problems.

d) Recognizes issues that would put a project at risk and alerts senior management.

Team Management:

a) Through an understanding of strengths, weaknesses, and respective roles, builds successful, inclusive, working relationships with and among all project team members (including substudy personnel, sponsors, and subcontractors).

b) Establishes and communicates to project team members the criteria and/or processes necessary to achieve a high level of quality and service.

c) Delegates tasks and ensures team member understanding of responsibilities and timelines to ensure that current deliverables and critical issues are addressed.

d) Encourages participation and input from team members as appropriate.

e) Holds cross-functional team members accountable for assignments with assistance from operations manager.

f) Provides constructive feedback about employee strengths, initiative, and developmental needs to line managers when appropriate.

Financial Management:

a) Understands components of a budget.

b) Demonstrates fiscal sensitivity and responsibility.

c). Creates, negotiates, and monitors budgets with assistance, collaborating with functional group or key research program (KRP) leaders as appropriate.

d) With guidance, able to work through the grant application/ award/ renewal process across the different DUMC departments.

e). Reviews and understands both site and sponsor contracts with assistance.

f). Collaborates with financial analyst to follow-up with sponsor regarding outstanding invoices and cash flow issues.

g) Recognizes out-of-scope activities and creates and negotiates out-of-scopes with assistance.

Data Management and Analysis:

a) Has a basic understanding of how to employ data and statistical analysis and statistical software tools such as STATA or SPSS.

b) Ability to generate and maintain a basic research database in platforms such as REDCap.

Accountability

a) Demonstrates openness and conveys self-awareness about project role and responsibilities.

b) Accepts responsibility for outcomes of work, even if task was delegated.

c) Admits mistakes and refocuses efforts.

d) Has the ability to be able to step back from details and see the bigger picture.

e) Acknowledges gaps in experience and uses past knowledge/experience in devising solutions and drawing upon others' knowledge and experience.

f) Demonstrates initiative to deal with unfamiliar situations.

g) Seeks and accepts feedback and acts constructively in response.

h) Has a highly developed sense of initiative.

Medical Writing:

a) Write and coordinate review/revision of clinical trial protocols for the Pharmacometrics KRPs.

b) Write and coordinate review/revision of clinical study reports, manuscripts, posters, presentations, pediatric investigation plans, and other documentation/reporting for the Pharmacometrics KRP.

Communication Skills

a) Listens well and probes for information.

b) Accepts differences of opinion.

c) Demonstrates clear and concise verbal and written communication skills for both internal and external audiences.

d) Keeps all relevant parties informed about important issues at the appropriate time.

e) Effectively communicates ideas in formal oral presentations to both internal and external parties.

f) Encourages open and honest communication.

Organizational Leadership

1. Supports Functional Group and DCRI non-project initiatives.

Grant Writing

1. Supports DCRI GPS in grant writing activities.

Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist, Medical Doctor (MD), or PharmD, plus two 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) plus a minimum of five years healthcare experience; or

2. Completion of a master's degree in Public Health, Health Administration or a related area with one year directly related clinical trials research experience; or

3. Completion of a bachelor's degree plus a minimum of three years directly related experience in clinical trials research; or

4. Completion of a bachelor's degree plus a minimum of four years closely related experience.

Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus two 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 Associate's degree in Clinical Trials Research related curriculum plus a minimum of five years healthcare experience; or 2. Completion of a Master's degree in Public Health, Health Administration or a related area with one year directly related Clinical trials research experience; or 3.Completion of a Bachelor's degree plus a minimum of three years directly related experience in clinical trials research; or 4. Completion of a Bachelor's degree plus a minimum of four years closely related research experience. **State of North Carolina license may be required.**

None required beyond that described above. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR 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.

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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.