CLINICAL TRIALS COORDINATOR II

Location
Durham, NC
Posted
Jul 14, 2017
Institution Type
Four-Year Institution

diversity employer



CLINICAL TRIALS COORDINATOR 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.

Demonstrate in-depth knowledge of study protocols, relevant SOPs and clinical endpoints through accurate, timely and efficient management of CEC events with proven ability to effectively support study start-up and routine study activities. Effectively conveys CEC study knowledge as requested for training of team members and new employees. Prepares presentations of CEC related study activates, including endpoint definitions and review process, for project teams and investigator meetings. Coordinates the work of CEC team members working on CEC aspects of the trial to ensure accurate and timely classifications of clinical events based on source documents and other clinical data, according to study specifications and SOPs. Effectively and efficiently resolves queries and questions from study team relative to CEC data. Manages and review process to ensure adherence to study specifications, including resolution of reviewer inconsistencies. Reviews CRF/eCRF to assure congruence with CEC Study protocol and endpoints specifications. Identifies and works to resolve issues that place data integrity at risk. Ensures team members receive and documents study specific training. Coordinates CEC aspects of interim analyses, and trial close out, providing input to report development, reviewing for accuracy and appropriateness to purpose. Applies proactive approach to identify, escalating as needed, potential study risks and quality concerns. Responsible for study adherence with quality, compliance and SOP standards. Provides input to management of project budgets and forecasting as well as review of scope of work and tasks. Demonstrates the ability to review data sets to identify unreported potential endpoints and serious adverse events. Other Duties:Other duties as assignedPerform other related duties incidental to the work described herein.Any travel up to 20% for CEC related activities as required inside and outside of the USA to accomplish responsibilities.

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

**State of North Carolina licensure may be required**

Prefer one year experience in directly related to CEC position or safety. Experience with and creating detailed oriented work instructions and using multiple databases, spreadsheets, and word processing software is also preferred.

Requisition Number
401287773

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1944 CLINICAL TRIALS COORDINATOR II

Job Family Level
80

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 Pharmacists plus a minimum of two years 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 four years healthcare experience; or
2. Completion of a Master's degree in Public Health, Health Administration or a related area with a minimum of one year directly related clinical trials research experience; or
3. Completion of a Bachelor's degree plus a minimum of two years directly related clinical trials research; or
4. Completion of a Bachelor's degree plus a minimum of three years closely related research experience.

**State of North Carolina licensure 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 forreasonable accommodation will be provided by each hiring department.

Auto req ID

91591BR

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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