CLINICAL RESEARCH COORDINATOR at Duke University

Posted in Other 17 days ago.

Location: Durham, North Carolina





Job Description:


School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.

Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.



Occupational Summary
Work Performed



  • Coordinates the advertisement, recruitment contact, scheduling and screening of human subjects for approved research protocols.

  • Adheres to DCRU standard operating procedures, Good Clinical Practices, and ICH guidelines as appropriate.

  • Coordinates all required activities with unit staff and participates in screening procedures as appropriate.

  • Plans for the advertisement and recruitment of human subjects for approved research protocols.

  • Uses approved mechanisms for the recruitment and screening of potential subjects.

  • Coordinates and participates in the timely recruitment of research subjects by initiating telephone interviews, scheduling screening appointments for potentially qualified subjects, and conferring with nursing, laboratory, and medical personnel to assure that research subjects chosen to participate in a trial have met all required criteria as specified in the protocol.

  • Performs screening activities for trial coordination by identifying appropriate candidates according to specific inclusion/exclusion criteria; presents study information to volunteers; collaborates with coordinator staff to provide informed consent sessions and obtains informed consent as appropriate, adhering to NIH, FDA and ICH guidelines throughout this process.

  • Participates in screening procedures required by protocols. Follows established GCP guidelines in the performance of study procedures and in the collection and documentation of clinical data.

  • Participates in quality assurance and quality control activities to ensure appropriate and effective conduct of each phase of the clinical trials and for the safety of study subjects.

  • Prepares and organizes materials and supporting documents to be presented in audits; participates in audits of clinical trials initiated by study sponsors and/or regulatory

  • Provides input into select aspects of study budgets; assures the availability of supplies and equipment; initiates requests for clinical and other purchases as appropriate.

  • Ensures compliance with protocol guidelines and ongoing requirements of regulatory agencies; identifies problems and/or inconsistencies and takes corrective action, reporting to management as appropriate; participates in interactions with management to address research process/procedure improvements as appropriate.

  • Prepares materials for various reports required by investigators, sponsors, and the IRB.

  • Provides input into the development of standard operating procedures (SOPs); participates in periodic review of SOPs providing updates and revisions. Maintains on going communication with faculty, study coordinators, investigators, and sponsors as appropriate to ensure for the safe and timely progression of clinical trials and adherence to protocol requirements.

  • Demonstrates knowledge and application of all privacy and safety standards as they relate to job responsibilities, human subjects, staff, and the general operation of the unit.




Minimum Qualifications
Education


Completion of an Associate's degree




Experience

Work requires a minimum of two years of relevant research experience. A Bachelor's degree may substitute for 2 years required experience.


Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob 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.