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ASSIST RESEARCH PRACTICE MANAGER

Employer
Duke University
Location
DoM Research Administration

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Administrative Jobs
Academic Affairs, Research Staff & Technicians
Employment Type
Full Time
Institution Type
Four-Year Institution

Job Details

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.

ASSIST RESEARCH PRACTICE MANAGER (1045) Job Description

Occupational Summary

Responsible to the Research Practice Manager (RPM) for oversight of study conduct for research studies within the assigned division(s) or cluster(s). Assist the RPM in the day-to-day management of CRU operations and people. Ensure that clinical research professionals and investigators are appropriately trained and performing activities in accordance with good clinical practice, CRU standards, institutional policy, and regulatory requirements. Assist in providing operational and study conduct metrics/reports to RPM.

Specifically within the Department of Medicine CRU, the Assistant Research Practice Manager (ARPM) is assigned to a team consisting of a number of divisions (or affiliates) within the Department of Medicine (DoM). The ARPM works closely with the financial staff to act as a clinical resource and help the team achieve project startup within the desired timeline. The DOM ARPM also works closely with the lead coordinator (RPL, divisional ARPM, Sr. CRC, etc.) in each division providing upper level management across the entire study team to ensure accountability for timely project progression and metrics are met as well as regulatory compliance. The ARPM will assist with operational and oversight duties within the assigned team as delegated by the RPM.

Work Performed

1. Management and Institutional Responsibility

Screen, interview, and hire clinical research professionals with faculty and RPM input. Collaborate with Duke Office of Clinical Research (DOCR) and other School of Medicine (SOM) resources to conduct onboarding, training, and professional guidance for clinical research professionals, including navigation through the Tier Advancement process. Assist with staff effort distribution, for the assigned divisions or clusters, to ensure that staff are appropriately assigned studies based on volume and individual staff competency. Conduct annual performance evaluations and performance improvement plans with staff; consulting with Human Resource Manager and RPM if needed. For assigned division(s) or cluster(s), oversee the operations of studies and provide regular updates to the RPM as needed. This may include study start up, enrollment, recruitment, closeout, continuing renewals, etc. Provide research metrics to RPM in order to advise on high-level decisions. Serve as an expert resource to assigned division (s) or cluster(s) with regard to study conduct and is knowledgeable about other resources at Duke. Continuously identify methods and work with the RPM to improve CRU and institutional procedures and policies.

2. Research Operations

Supervise and provide guidance on research operations for the studies within the assigned division(s) or cluster(s). This includes: a) regulatory and institutional policies and processes, b) screening, c) recruitment and retention, d) study monitoring, e) audit visits, f) participant and study level documentation, g) study visits, h) SOPs, i) specimen management, j) IND/IDE/ITP documentation, k) investigational product, and 1) contracts and agreements. Ensure that key personnel are properly trained and document training according to institutional and regulatory policies in a timely fashion. Assist clinical research professionals in the development of participant recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions. Should be knowledgeable about SOM resources available to teams for assistance. Conduct internal quality assurance audits of specific studies and assists in preparation for external audits. Review and respond to audit reports, and develop and implement corrective action plans in a timely manner when problems are identified. Lead multidisciplinary team meetings by establishing attendance lists, agendas, creating action items, and following up on action items.

3. Safety and Ethics

Monitor compliance with institutional requirements and provide guidance to assigned division(s) or cluster(s), at Duke pertaining to: a) developing and submitting documentation and information for IRB review, b) preparing and submitting documents needed for regulatory and safety reporting to sponsors and other agencies, c) identifying and documenting adverse event information, d) conducting and documenting consent, and developing consent documents and processes.

4. Data

Monitor compliance with institutional requirements and provide guidance to assigned division(s) or cluster(s) at Duke pertaining to a) quality data collection and capture, b) data flow plans, c) data security and provenance, and d) data quality assurance. Guides assigned division(s) or cluster(s) to institutional resources as necessary for study compliance with data processes and policies (e.g., ISO, IRB). Performs data audits on specific studies and provides corrective action as needed. Assists with and provides guidance on the implementation of new technologies and data capture requirements across the CRU.

5. Scientific Concepts

Assist RPM with ensuring appropriate documentation of scientific review processes, including decisions made by scientific reviewers/review committees.

6. Site and Study Management

Collaborate with CRU Financial Practice Manager (FPM) and RPM to evaluate the feasibility of new studies. Provide input and information to assist the RPM in making decisions regarding study selection. Work with financial staff in developing and negotiating budgets with sponsors. Should be knowledgeable about SOM resources available to teams for assistance. Review the finances of ongoing trials on a regular basis in collaboration with the CRU Director, RPM, PIs, Financial Manager and other clinical research professionals. Facilitate efforts to address budget related issues. Serve as an expert resource to clinical research professionals and outside agencies with regard to study specific protocol requirements and problem solving related to clinical, logistical, financial and regulatory concerns. Ensure that studies within the assigned division(s) or cluster(s) are conducted in compliance with institutional requirements and policies. Acts as the primary contact during study startup and intervenes when study teams have a conflict with sponsors and/or CROs.

7. Leadership and Professionalism

Keep current with research updates and oversee implementation of new policies and regulations among staff members. Evaluate and implement professional development and/or training programs offered through DOCR

(e.g., Research Professionals Network (RPN), Research Wednesdays) to encourage staff retention, continuous improvement, and development. Contribute to and represent the institution in internal and external groups related to research or therapeutic area (e.g., institutional initiatives or committees). Uses advanced subject matter expertise in clinical research activities to solve complex problems across assigned division(s) or cluster(s). Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently. Create a team environment with a culture that fosters communication. Communicate effectively across the assigned division(s) or cluster(s) about new policies, regulatory updates, and institutional SOP changes. Develop and implement solutions within assigned division(s) or cluster (s) to improve the research process. Demonstrate resilience, leadership, and actively facilitate change within CRU.

Required Qualifications at this Level

Education/Training: Work requires completion of a Bachelor's degree. ACRP or SOCRA certification preferred.

Experience: Work requires a minimum of six years of related experience, with at least four years in a research setting. A Master's degree may substitute for two years of related experience.

Minimum Qualifications

Education

Work requires completion of a Bachelor's degree. ACRP or SOCRA certification preferred.

Experience

Work requires a minimum of six years of related experience, with at least four years in a research setting. A Master's degree may substitute for two years of related 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.

Organization

Read our Diversity Profile History

Duke University was created in 1924 by James Buchanan Duke as a memorial to his father, Washington Duke. The Dukes, a Durham family that built a worldwide financial empire in the manufacture of tobacco products and developed electricity production in the Carolinas, long had been interested in Trinity College. Trinity traced its roots to 1838 in nearby Randolph County when local Methodist and Quaker communities opened Union Institute. The school, then named Trinity College, moved to Durham in 1892, where Benjamin Newton Duke served as a primary benefactor and link with the Duke family until his death in 1929. In December 1924, the provisions of indenture by Benjamin’s brother, James B. Duke, created the family philanthropic foundation, The Duke Endowment, which provided for the expansion of Trinity College into Duke University.Duke Campus

As a result of the Duke gift, Trinity underwent both physical and academic expansion. The original Durham campus became known as East Campus when it was rebuilt in stately Georgian architecture. West Campus, Gothic in style and dominated by the soaring 210-foot tower of Duke Chapel, opened in 1930. East Campus served as home of the Woman's College of Duke University until 1972, when the men's and women's undergraduate colleges merged. Both men and women undergraduates now enroll in either the Trinity College of Arts & Sciences or the Pratt School of Engineering. In 1995, East Campus became the home for all first-year students.

Duke maintains a historic affiliation with the United Methodist Church.

Home of the Blue Devils, Duke University has about 13,000 undergraduate and graduate students and a world-class faculty helping to expand the frontiers of knowledge. The university has a strong commitment to applying knowledge in service to society, both near its North Carolina campus and around the world.

Mission Statement

Duke Science"James B. Duke's founding Indenture of Duke University directed the members of the University to 'provide real leadership in the educational world' by choosing individuals of 'outstanding character, ability, and vision' to serve as its officers, trustees and faculty; by carefully selecting students of 'character, determination and application;' and by pursuing those areas of teaching and scholarship that would 'most help to develop our resources, increase our wisdom, and promote human happiness.'

“To these ends, the mission of Duke University is to provide a superior liberal education to undergraduate students, attending not only to their intellectual growth but also to their development as adults committed to high ethical standards and full participation as leaders in their communities; to prepare future members of the learned professions for lives of skilled and ethical service by providing excellent graduate and professional education; to advance the frontiers of knowledge and contribute boldly to the international community of scholarship; to promote an intellectual environment built on a commitment to free and open inquiry; to help those who suffer, cure disease, and promote health, through sophisticated medical research and thoughtful patient care; to provide wide ranging educational opportunities, on and beyond our campuses, for traditional students, active professionals and life-long learners using the power of information technologies; and to promote a deep appreciation for the range of human difference and potential, a sense of the obligations and rewards of citizenship, and a commitment to learning, freedom and truth.Duke Meeting

 “By pursuing these objectives with vision and integrity, Duke University seeks to engage the mind, elevate the spirit, and stimulate the best effort of all who are associated with the University; to contribute in diverse ways to the local community, the state, the nation and the world; and to attain and maintain a place of real leadership in all that we do.”

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