CLINICAL TRIALS PROJECT LEADER I, DCRI - Outcomes

Location
Durham, NC
Posted
Apr 13, 2017
Institution Type
Four-Year Institution

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

Occupational Summary

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.

Work Performed

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.
Follow established guidelines in the collection of clinical data and administration of clinical trials; assist in the determination guidelines for new protocols. Assist principal investigator and other team members in the development of plans, time lines, and processes for clinical research studies, contribute to the ongoing analysis and modification of protocols; recommend amendments to study protocols as appropriate.
Confer with site coordinators and physicians to explain protocol and 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 research team and provide feedback to staff's supervision on a routine basis. Participate in conjunction with the principal investigator in the final negotiations of trial budget and contract.
Prepare a variety of narrative and analytical reports, documents, and correspondence for contracting agencies, team members, participating departments and senior management regarding trial status; recommend corrective action as necessary.

Perform other related duties incidental to the work described herein.



Requisition Number
401149620

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

Education

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 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; or
2. Completion of a master's degree in Public Health, HealthAdministration or a related area with one year directly relatedclinical trials research experience; or
3. Completion of a bachelor's degree plus a minimum of threeyears directly related experience in clinical trials research; or
4. 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

Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, genderidentity, 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/ormental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department

Auto req ID

82337BR

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.

PI97509813