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Associate Director, Clinical Trials Operations, Duke Cancer Network

Regular Full Time Durham, North Carolina
Requisition Number: 218608
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Hybrid 80% Remote 

Associate Director, Clinical Trials Operations, Duke Cancer Network

POSITION SUMMARY

The Associate Director is responsible for oversight of clinical research operations within the Duke Cancer Network, through developing, implementing and overseeing activities involved in assuring compliance with the appropriate statutes, regulations, Good Clinical Practice (GCP) and IRB-approved clinical trials. This position requires project management and oversight of the clinical coordination of multiple complex oncology research projects across the Duke Cancer Network (DCN) affiliate sites which involves the development and maintenance of clinical research programs that is compliant with federal, state, and institutional research guidelines. This Associate Director provides direct supervision to multiple research staff involved in clinical operations and ensures that designated research personnel are performing study activities in accordance with GCP, Duke policy and regulatory requirements using Standard Operating Procedures (SOPs) and periodic monitoring.

JOB RESPONSIBILITIES

The following description of job responsibilities and standards reflects the major duties of the job but does not describe minor duties or other responsibilities that are assigned from time to time.

     Research Program Oversight

  • Oversees the daily operations, management, and quality assurance of clinical research programs at Duke-affiliated sites

  • Supervises activities performed by research staff involved in study conduct and ensures that activities are performed in accordance with Good Clinical Practice standards, Duke policies and procedures, applicable regulatory requirements, and according to the IRB-approved protocol

  • Monitors the status of study start-up including contract execution, IRB approval, site initiation visits, and protocol education

  • Monitors the progress of ongoing studies including enrollment, data collection, event reporting, data completion, and study close-out activities

  • Oversees accrual rates at sites to determine if sites are meeting accreditation research participation requirements such as; ACoS, Alliance, NAPBC, etc.

  • Establishes and manages relationships with Duke Investigators and study teams to identify clinical trials of interest to Duke affiliate sites; participates in routine Duke Cancer Institute disease group and administrative research meetings

  • Prepares routine reports and analyses reflecting the research program progress and site-specific strategic annual research goals

  • Maintains knowledge of oncology nursing clinical practice standards, The Joint Commission-related safety requirements, FDA and OHRP requirements for human subjects research protections

  • Oversees the development of study-specific oncology treatment orders

Management and Work Culture:

  • Creates a supportive team environment internally and with affiliated program members

  • Supervises clinical research operations direct reports, is responsible for interviewing and hiring staff, new employee orientation, completing annual and routine professional coaching, assisting employees with annual goals and professional development plans

  • Plans and assigns work for the team to ensure proper distribution of responsibility, while leveraging each team member’s strengths and supporting opportunities for continued professional development

  • Provides access to developmental/educational/training opportunities to staff including mentoring, competencies assessment, and development.

  • Maintains liaison with investigators, industry representatives, research personnel, and staff to solve specific operational problems associated with the affiliate research program and improve efficiency, quality, and business excellence outcomes

Finance and Regulatory:

  • Assists in the evaluation of protocol feasibility for potential studies including staffing needs, budgetary requirements, clinical and logistical considerations, patient data analytics, and protocol portfolio gaps

  • Assists with the development of policies and procedures for research  operations; provides ongoing education to the research team to ensure compliance with established practices and to implement new policies and procedures

  • Oversees audits conducted by Duke, sponsors, and regulatory authorities.  Reviews and responds to audit reports, and develops and implements corrective action plans in a timely manner

  • Participates in annual budget development and strategic planning for ensuring there are adequate resources to support the DCN affiliate research programs

  • Completes appropriate accounting and financial paperwork for filing meeting and travel expense receipts and procurement card transactions as instructed and in accordance with Duke University’s standard procedures 

Understands study-specific clinical trial billing nuances and works with the DCN research team and affiliate sites to ensure the accuracy of patient billing. Participates in research patient financial chart audits related to research-provided services as requested.

Required Qualifications at this Level

Work requires a minimum Bachelor’s degree in Nursing, Biology, Clinical Research, Physiology, Public Health, a related scientific field, or health-related field such as pharmacy. Master’s degree is highly preferred. 

Experience:

  • Minimum of 5 years experience in conducting clinical research required; a Minimum of 3 years of progressive supervisory or program management experience required.
  • Knowledge of HHS and FDA human protection regulations.
  • Certification in Clinical Research is strongly recommended (SOCRA, ACRP).
  • Experience with coordinating oncology clinical trials, including phases I-IV industry-sponsored, cooperative group, and investigator-initiated clinical trials.

Degrees, Licensure, and/or Certification: Preferred current RN licensure in the state of North Carolina, and/or clinical research certification.

Knowledge, Skills, and Abilities:

Clinical research operations

Oncology

Human subjects research protections

Project management & oversight

Data management

Ability to travel to affiliated sites (mainly within 4-hour drive or short flights to some regional or  national, overnight travel may be required) Travel may consume 10% of the role; work is primarily remote or in-office/remote hybrid.

Distinguishing Characteristics of this Level

  • Ability to analyze trends and data and to present findings to various stakeholders.
  • Effective verbal and written communication skills, excellent problem solving skills, Ability to multitask is essential, highly organized with attention to detail, Teaching and mentoring abilities.
  • Computer literacy, competency in Microsoft word products and the ability to understand complex databases (REDCap, electronic research management systems, electronic health records).

Job Code: 00005202 ASSOC ADMIN SR, MC BUS DEV/MKT
Job Level: H2

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 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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