ASSIST RESEARCH PRACTICE MANAGER


diversity employer



ASSIST RESEARCH PRACTICE MANAGER
Duke Office of Clinical Research


Occupational Summary

Responsible to the Research Practice Manager for the day-to-day operations associated with the Duke Office of Clinical Research (DOCR) Clinical Research Coordinators (CRCs/CRNCs) and other research staff participation in clinical research studies at Duke-as-a-site. Ensure that CRCs and designated research personnel are performing study activities in accordance with Good Clinical Practice (GCP), Duke Policy and regulatory requirements.

Work Performed

  • An assistant to the RPM. Provide supervision of CRCs/CRNCs and other research staff. Delegate project related tasks. Aware of various funding sources including industry or federal grants.
  • Ensure that CRCs/CRNCs and other research staff are trained for new studies/projects.
  • Maintain current training records and required certifications.
  • Develop an individualized orientation plan with new staff and provide the level of oversight needed by the new staff member.
  • Monitor the performance and progress of the CRCs/CRNCs and other research staff. Ensure that the CRCs/CRNCs and other research staff coordinate IRB submissions, participant recruitment, screening, consent and enrollment, data collection, safety reporting, drug accountability, and record retention as required.
  • Plan and coordinate staffing needs based on current and future workload requirements. Screen, interview and hire study coordinators and other research staff in conjunction with stakeholder input.
  • Coordinate and assign study coordinators and other research staff to individual studies and research related activities
  • Conduct regular meetings with study coordinators and other research staff. Ensure that staff informed DOCR departmental and institutional activities, goals, and policies and procedures.
  • Participate in project work that could include but is not limited to: IRB submissions, participant recruitment, screening, consent and enrollment, data collection, safety reporting, drug accountability, and record retention.
  • Monitor the status of start-up timelines for new studies covered by DOCR CRCs and CRNCs including IRB approval and contract execution, if applicable.
  • Monitor the progress of ongoing studies including enrollment, data collection, and close-out
  • Serve as a resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem-solving related to clinical, logistical, financial and regulatory issues.
  • Assist PIs, study coordinators and research staff in use of available subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.


REPORTING RELATIONSHIP: The Assistant Research Practice Manager (ARPM) will report to the DOCR Research Practice Manager.



Requisition Number
401307113

Location
Durham

Duke Entity
MEDICAL CENTER

Job Code
1045 ASSIST RESEARCH PRACTICE MANAGER

Job Family Level
68

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 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.

Education

Allied Health degree or Associates degree in Clinical Trials Research and 8 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred. OR RN or Bachelor's degree and 6 years of related experience, with at least four years in a research setting. ACRP or SOCRA preferred. OR Master's degree and 4 years of related experience, with at least two years in a research setting. ACRP or SOCRA preferred.

Experience

No experience is required beyond what is specified above.

Auto req ID

92675BR

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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