Project Leader II, Clinical Trials

Location
Durham, NC
Posted
Apr 25, 2017
Institution Type
Four-Year Institution

Project Leader II, Clinical Trials
DCRI - Mega Trials Operations

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 Clinical Research Institute; 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 thesuccessful management of phase II, III, and IV clinical trials research projects conducted by principal investigator (s) at Duke Clinical Research Institute; 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. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

EDUCATION/TRAINING 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) 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 offour 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

Requisition Number
401205847

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1639 CLINICAL TRIALS PROJECT LEADER II

Job Family Level
78

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 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.

Education

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

Auto req ID

85822BR

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.

PI97607399