CLINICAL TRIALS PROJECT LEADER II

Location
Durham, NC
Posted
Jul 20, 2017
Institution Type
Four-Year Institution

diversity employer



CLINICAL TRIALS PROJECT LEADER II
DCRI - Clinical Events Commitee

Who We Are:
As the world's largest academic clinical research organization and part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known for conducting groundbreaking multinational clinical trials, managing major national patient registries, and performing landmark outcomes research. We are dedicated to advancing clinical research by promoting innovation, education, scientifically designed studies, and operationally efficient clinical trial conduct.
  • 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 Is.
  • Participate in conjunction with the principal investigator in initial contacts with outside vendors and internal functional groups for potential projects including early trial budget negotiations and contract and proposal development.
  • Manages and responsible for project budgets in concert with project team and financial analyst.
  • Manages assigned staff, develops, writes and completes individual employee performance improvement plans, completes employee evaluations in appropriate time frame, manages assigned employee career progression.
  • Recommend and develop guidelines and refinement of guidelines in the collection of clinical data and administration of clinical trials; assist in the determination of guidelines for new protocols.
  • Develops CEC project plan in concert with team members to include time lines, and processes for clinical research studies, milestones, DMC activities; coordinate the ongoing analysis and modification of protocols; recommend amendments to study protocol and CEC Charter as appropriate.
  • Confer with site coordinators and physicians to explain protocol and to elicit compliance with regulations (if applicable); assure adherence to Federal Drug Administration and protocol guidelines; identify potential problems and/or inconsistencies and take action as appropriate.
  • Develop and implement training and new processes in CEC to ensure consistency in work flow and CEC SOPs.
  • Ensures CEC projects are audit compliant and develops performance and process improvement strategies when applicable.


Requisition Number
401297219

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


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

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.

Auto req ID

91996BR

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.

PI98744300