• Location: Durham, NC
  • Posted: Jan 4, 2020

Job Description

School of Medicine:

Established in 1930, Duke University School of Medicine is the youngest of the nations 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

Responsible to theChildrensCRU(CCRU)Research Practice Manager(RPM)for theoversight of study conduct for research studies with in the assigned division(s). Assist the RPM in theday-to-day operations of the CRUoperations and people.Ensure that Clinical Research Coordinators,designated research personneland investigatorsare appropriatelytrained andperforming study activities in accordance with Good ClinicalPractice (GCP), DukePolicy,regulatory requirements using Standard Operating Procedures (SOPs), CCRU policy andperiodic monitoring.Maintain a close, collaborative working relationship with the division Principal Investigators (PIs) within the assigneddivision(s) to manage research studies. Build and maintain effective relationships with key personnel, clinic and regulatory resources within the CCRU and with the SOM. Assist in providing operational and study conduct metrics/reports to the RPM.

Work Performed(100%)

Serve as an assistant to the CCRU RPM with oversight of division peers and delegation of project related tasks to others on the study.

Overseethe adherence to policiesand regulationsrelated to study conduct.Ensure that new studies are initiated appropriately and monitor the performance and progress of ongoing studies. Ensure appropriate coordination of IRB submissions, participant recruitment, screening, consent and enrollment, data collection, safety reporting, drug accountability, and record retention.

Supervise the day-to-day operations of the CRU related to study conduct including IRB submissions and renewals; protocol initiation; patient recruitment, screening, consent, enrollment and follow-up; data collection; safety reporting; drug accountability; studycloseoutand record retention.

Review and supervise activities performed by study coordinators and other research staff involved in study conduct and ensure that activities are performed in accordance with Good Clinical Practice standards, DukePoliciesand procedures, and applicable regulatory requirements.

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 faculty input.

Coordinate and assign study coordinators and other research staff to individual studies and research related activities.

Supervise study coordinators and other research staff and perform various personnel actions including, but not limited to, hiring, performance planning and evaluation, scheduling and work assignments, disciplinary action, promotions and transfers.

Conduct regular meetings with study coordinators and other research staff. Ensure that staff are kept abreast of CRU, departmental and institutional activities, goals, and policies and procedures.Attend regular ARPM meetings with the RPM.

Plan and coordinate orientation and ongoing training for study coordinators and other research staff. Ensure that current training records and required certifications are maintained.

Collaborate with the CRU Finance PracticeManager (FPM) andRPM to evaluate the feasibility of new studies including staffing and budgetary requirements, clinical and logistical considerations, and competing studies. Provide input regarding studyselection.

Ensure appropriate planning and coordination prior to the approval and initiation of new protocols; including the accurate and timely development of the charge assignment grid basedon the schedule of events and protocol. Assist in budget/contract negotiations with sponsors.Collaborate with division study coordinators to confirm entry intoMaestro Care(MC) at the time of enrollment, with linking the patient to the Research Subject Record (RSH) record. For projectswith MC orderables, link tothe study encounter and the timeline prior to close of the study encounter.

Monitor the status of start-up timelines for new studies including IRB approval and contract execution. Monitor the progress of ongoing studies including enrollment, data collection, and close-out

Serve as an expert resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements andproblem solvingrelated to clinical, logistical, financial and regulatory issues.

Collaborate with CRU Financial Practice Manage(FPM) and RPM to be knowledgeable of various funding sources including industry or federal grants.

Review the finances of ongoing trials on a monthly basis in conjunction with the CRU Director, PIs, Financial Manager and study coordinators. Facilitate efforts to address budget-related issues.

Assist PIs, study coordinators and research staff in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.

Participateinaudits conducted by the OARCgroup, 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.

Develop an internal ClinicalQuality Management Plan (CQMP)and conductinternal monitoring on studies as needed.

Ensure that the CRU has up-to-date standard operating procedures, that staff are knowledgeable regarding SOPs, and that all activities are conducted in accordance with SOPs.

Division study coordinators will report directly to the Assistant Research Practice Manager (ARPM) and the ARPM to the RPM.

Minimum Qualifications


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.


No experience is required beyond what is specified above.

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 ideasan 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.

Duke Health

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Durham, NC 27708

Phone: (919) 684-5600

Fax: (919) 684-5600