CLINICAL TRIALS PROJECT LEADER III, DCRI - Outcomes

Location
Durham, NC
Posted
Apr 22, 2017
Institution Type
Four-Year Institution

CLINICAL TRIALS PROJECT LEADER III, DCRI - Outcomes
DCRI - Outcomes


Occupational Summary
Develop, coordinate, and implement research and administrative strategies essential to the successful management of phase II, III and IV clinical trials research projects conducted by principal investigator(s) at Duke University Medical Center; perform a variety of duties involved in the organization, documentation and compilation of clinical research data; function in preceptor capacity for Clinical trials Project Leader I's and II's.

Work Performed
Develop, coordinate, and implement research and administrative strategies essential to the successful management of phase II, III and/or IV clinical trials research projects conducted by principal investigator(s) at Duke University Medical Center; perform a variety of duties involved in the organization, documentation and compilation of clinical research data; function in preceptor capacity for Clinical Trials Project Leader I's and II's.
Develop systems for the establishment and refinement of guidelines in the collection of clinical data and administration of clinical trials; design and evaluate alternative methodology as necessary.
Advise and assist principal investigator and other team members in the development of plans, time lines, and processes for clinical research studies; coordinate the ongoing analysis and modification of protocols; recommend amendments to study protocols as appropriate.
Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations; assure adherence to Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.
Coordinate and lead the work of the Project Leader I and II staff and research team and provide feedback to staff's supervisor on a routine basis; conduct cross functional research team meetings as needed.
Advise and assist the principal investigator in initial contacts and development of relationships with outside partners and internal functional groups for potential projects including trial budget and contract negotiations.
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.



Requisition Number
401225812

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


Education

Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus four 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 seven years healthcare experience; or
2. Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or
3. Completion of a bachelor's degree plus a minimum of five years directly related experience in clinical trials research; or
4. Completion of a bachelor's degree plus a minimum of six 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, genetic information, gender, 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.

Auto req ID

86960BR

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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