CLINICAL RESEARCH NURSE COORDINATOR

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

CLINICAL RESEARCH NURSE COORDINATOR
Medicine - Gastroenterology

Coordinate the day-to-day operations of the clinical trials.

Screen and enroll subjects, collect specimens, prepare specimens for laboratory analysis. Enter data into database.

Maintain all study required documentation.

Prepare and distribute study medications.

Supervise and provide guidance to lower level personnel involved in the implementation of clinical trials.

Responsible for patient recruitment, screening, consent, enrollment and follow-up; data collection; safety reporting; study close-out and record retention.

Ensure that activities are performed in accordance with Good Clinical Practice standards, Duke policies and procedures, and applicable regulatory requirements.

Ensure compliance with protocol guidelines and requirements of regulatory agencies.

Participates in feasibility assessment of potential clinical trials, focusing on having adequate space, patient population, timelines and financial resources to carry out the requirements of the clinical trial.

Assist PI's in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.

Function as primary point of contact for study participants.

Collect data from patient charts, questionnaires, medical records, interviews; prepare appropriate documentation.

Ensure compliance with protocol guidelines and requirements.

Prepare IRB submissions and renewals; protocol initiation, amendments.

Ability to provide training to lower level personnel related to IRB submissions.

Provide orientation and training to new personnel.

Function as mentor.

Participate in audits conducted by the CTQA group, sponsors, and regulatory authorities.

Review and respond to audit reports, and develop and implement corrective action in a timely manner when problems in research practice are identified.

Requisition Number
401217696

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1203 CLINICAL RESEARCH NURSE COORDINATOR

Job Family Level
54

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 BSN or Associate's Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelor's degree in Nursing (or higher) will be required to enroll in an appropriate BSN program within two years of their start date and to complete the program within five years of their start date. Experience: Twelve months of appropriate clinical experience is required.

Auto req ID

86441BR

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.

PI97510333