Project Leader I, Pharmacometrics

Location
Durham, NC
Posted
May 06, 2017
Institution Type
Four-Year Institution

Project Leader I, Pharmacometrics
Pharmacometrics


Occupational Summary
Develop, coordinate, and implement research and administrativestrategies essential to the successful management of phase II, IIIand/or IV clinical trials research projects conducted by principalinvestigator(s) at Duke University Medical Center; perform a variety ofduties involved in the organization, documentation and compilation ofclinical research data.
Work Performed
Develop, coordinate, and implement research and administrativestrategies essential to the successful management of phase II, III, andIV clinical trials research projects conducted by principalinvestigator(s) at Duke University Medical Center; perform a variety ofduties involved in the organization, documentation and compilation ofclinical research data.Follow established guidelines in the collection of clinical data andadministration of clinical trials; assist in the determinationguidelines for new protocols.Assist principal investigator and other team members in thedevelopment of plans, time lines, and processes for clinical researchstudies, contribute to the ongoing analysis and modification ofprotocols; recommend amendments to study protocols as appropriate.Confer with site coordinators and physicians to explain protocol andelicit compliance with regulations; assure adherence to Federal DrugAdministration and protocol guidelines; identify potential problemsand/or inconsistencies and take action as appropriate.Coordinate and lead the work of the research team and provide feedbackto staffs supervision on a routine basis.Participate in conjunction with the principal investigator in thefinal negotiations of trial budget and contract.Prepare a variety of narrative and analytical reports, documents, andcorrespondence for contracting agencies, team members, participatingdepartments and senior management regarding trial status; recommendcorrective action as necessary.Perform other related duties incidental to the work described herein.The above statements describe the general nature and level of workbeing performed by individuals assigned to this classification.This is not intended to be an exhaustive list of all responsibilitiesand duties required of personnel so classified.

Requisition Number
401253236

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1635 CLINICAL TRIALS PROJECT LEADER I

Job Family Level
85

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 Employercommitted to providing employment opportunity without regard to anindividual'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 mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.

Education

Work requires graduation from an accredited degree program providingclinical training as a Registered Nurse (RN), Physician's Assistant(PA) or Pharmacist plus two 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 Associatesdegree in Clinical Trials Research related curriculum plus aminimum of five years healthcare experience; or2. Completion of a master's degree in Public Health, HealthAdministration or a related area with one year directly relatedclinical trials research experience; or3. Completion of a bachelor's degree plus a minimum of threeyears directly related experience in clinical trials research; or4. Completion of a bachelor's degree plus a minimum of four 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

89343BR

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.

PI97766736