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ASSOC DEAN, CLINICAL RESEARCH

Job Title: ASSOC DEAN, CLINICAL RESEARCH
Job Code: 1226
FLSA: E
Job Level: 98
Revised Date: 02/01/2022
Job Family: JF 28

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Occupational Summary

Design, plan and implement the operations, coordination, and management of clinical research trials at Duke University Medical Center including: development of study protocols, IRB submissions, hiring, management, training and evaluation of study staff, (including salary/position adjustments), oversight and management of study subcontracts, interfacing with investigative team (establishing meetings, transfer of data and study specimens, and coordination of tasks) subject recruitment, data collection, intervention development and dissemination, documentation, tracking and database development, on going analysis of recruitment, study accrual projections, data analysis, research presentations, manuscript preparation (primary authorship and co-authorship), and assist with grant preparation.

Work Performed

Develop and maintain liaison with clinical trials participants including, but not limited to, researchers clinicians, university administration, Food and Drug Administration, industry sponsors of research and other to manage activities and facilitate communications; prioritize new projects and maintain current sponsor relationships to include clinical trials outside the United States.

Coordinate, through accountable support personnel, the establishment of clinical trials schedules, task assignments and allocation of manpower and equipment to ensure conformance with specified objectives.

Perform development and fundraising activities for the clinical trials group.

Implement and develop operating policies and procedures for Research Operations team; conduct meetings with staff to ensure compliance with established practices, to implement new policies and to keep employees informed of current changes and standards.

Manage automated systems as appropriate to support needs of the clinical trial project teams.

Advise and participate in the review and selection of a Clinical Trial Management System.

Prepare reports and analyses reflecting progress, adverse trends and appropriate recommendations or conclusions.

Direct various personnel functions including, but not limited to, hiring, merit recommendations, promotions, transfers and vacation schedules.

Work with managers of research and business operations to coordinate work with investigating teams to insure we provide collaborative and efficient service.

Coordinate the day to day operations of Management Teams related to study conduct.

Meeting with study team, Research Practice Manager, statistician and Investigator to determine needs.

Study Design, enrollment feasibility, institutional feasibility.

Insure adequate quantitative assessment to include informatics, review, data management review.

Provide this service through REDCap or other data management platform when needed (e.g., referral to DCRI for a 21 CFR part 11 compliant system).

Provide recommendations regarding subject recruitment, screening, consent, enrollment and follow-up as needed.

Insure data provenance and data collection in a central database repository.

Collaborate with Duke IT team to insure adequate data storage and service on a regular basis.

Meeting with study team, Finance Practice Manager and Investigator to assist with efficient IRB submissions and renewals; contract or agreement completion, grid review, template for calendar of events for the purposes of accrual accounting, fund code determination and other requirements necessary for protocol initiation.

Ensure that subjects (for included studies) are entered into the CTMS Registry in an accurate and timely manner.

Supervise the development of the Clinical Research Training and Communications Office.

Assist the Department Manager with collecting and unifying all appropriate School of Medicine Clinical research content, insure the production of a modern website using most recent Duke Medicine templates, and develop new newsletter and information notification format.

Develop new scripts for Investigator and Coordinator notices Supervise the development and unification of the Clinical Research and Institutional Review Board education program develop monthly to quarterly training program for new house staff research teams and assist with RMT training in a group setting.

Revamp current education system as suggested by a committee of appropriate stakeholders.

Continue CITI module program Conduct regular meetings with Research Operations staff.

Ensure that staff is informed of SBR, departmental and institutional activities, goals, and policies and procedures.

Collaborate with Biostatistics & Bioinformatics (B&B) statisticians and provide input as it relates to budget and logistical considerations for study design, data collection, cleaning, and transfer.

Monitor 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 closeout.

Collaborate with bio banking initiatives across Duke.

Assist study teams in adopting central informatics solution for tracking of biological specimens.

Ensure compliance with protocol guidelines and requirements for regulatory agencies; identify and report problems to PI and/or regulatory agencies; track participant progress including documentation of adverse events; recommend corrective action accordingly.

Represent Duke in local and national professional associations by serving on committees and presenting at conferences; stay current with regulatory standards and contribute to the knowledge of the profession.

Perform other related duties incidental to the work described herein.

The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

Required Qualifications at this Level

Education/Training

Allied Health degree or Associates degree in Clinical Trials Research and 14 years of related experience, with at least seven years in a research setting. ACRP or SOCRA required. OR RN or Bachelor's degree and 12 years of related experience, with at least seven years in a research setting. ACRP or SOCRA Required. OR Master's degree and 10 years of related experience, with at least seven years in a research setting. ACRP or SOCRA Required.

Experience

No additional experience required beyond requirements listed above.

Skills


The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.


Duke University 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 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.