Project Leader III, Clinical Trials DCRI

Location
Durham, NC
Posted
Jun 03, 2017
Institution Type
Four-Year Institution

diversity employer



Project Leader III, Clinical Trials DCRI
DCRI - Project Management

Occupational Summary:

Develop, coordinate, and implement research and administrativestrategies essential to the successfulmanagement of phase II, III and IV clinical trials research projectsconducted by principal investigator(s)at Duke Clinical Research Institute (DCRI); perform a variety of dutiesinvolved in the organization,documentation and compilation of clinical research data; function inpreceptor capacity for Clinical trialsProject Leaders I and II.

Work Performed:

Develop, coordinate, and implement research and administrativestrategiesessential to the successfulmanagement of phase II, III and/or IV clinical trials research projectsconducted by principal investigator(s) at DCRI; perform a variety of duties involved in the organization,documentation and compilation ofclinical research data; function in preceptor capacity for ClinicalTrials Project Leaders I and II.Develop systems for the establishment and refinement of guidelines inthe collection of clinical dataand administration of clinical trials; design and evaluate alternativemethodology as necessary.

Advise and assist principal investigator and other team members in thedevelopment of plans, timelines, and processes for clinical research studies; coordinate theongoing analysis and modification ofprotocols; recommend amendments to study protocols as appropriate.Confer with sitecoordinators and physicians to explain protocol and toelicit compliance withregulations; assure adherence to Federal Drug Administration andprotocol guidelines; identify potentialproblems and/or inconsistencies and take action as appropriate.Coordinate and lead the work of the Project Leader I and II staff andresearch team and providefeedback to staff#s supervisor on a routine basis; conduct crossfunctional research team meetings as needed.

Advise and assist the principal investigator in initial contacts anddevelopment of relationships withoutside partners and internal functional groups for potential projectsincluding trial budget and contractnegotiations.Perform other related duties incidental to the work described herein.The above statements describe the general nature and level of workbeing performed by individualsassigned to this classification. This is not intended to be anexhaustive list of all responsibilities andduties required of personnel so classified.

EDUCATION/TRAINING

Work requires graduation from an accredited degree program providingclinical training as a RegisteredNurse (RN), Physician#s Assistant (PA) or Pharmacist plus four years ofhealthcare experience; oroneof the following equivalents:
1. Completion of an allied health degree (e.g., Respiratory Therapy,Radiologic Technology, LicensedPractical Nurse) plus a minimum of seven years healthcare experience; or
2. Completion of a master#s degree in Public Health, HealthAdministration or a related area withthreeyears directly related clinical trials research experience; or
3. Completion of a bachelor's degree plus a minimumof five yearsdirectly related experience inclinical trials research; or4. Completion of a bachelor's degree plus a minimum of six 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

Requisition Number
401267028

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1813 CLINICAL TRIALS PROJECT LEADER III

Job Family Level
73

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 four 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 seven years healthcare experience; or2. Completion of a master's degree in Public Health, HealthAdministration or a related area with three years directly relatedclinical trials research experience; or3. Completion of a bachelor's degree plus a minimum of five yearsdirectly related experience in clinical trials research; or4. Completion of a bachelor's degree plus a minimum of six 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

90219BR

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.

PI98024659