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.

Position Summary:

Manage the development, coordination and implementation of clinical operations site management and clinical monitoring responsibilities for assigned projects with guidance, including trial- specific processes and systems, and daily supervision of the Clinical Operations team responsible for site management and clinical monitoring in accordance with contractual agreements, department guidelines, SOPs, applicable international federal and state regulations, and ICH guidelines.

Work Performed:

Provide leadership for the Clinical Operations project team responsible for site management working in close collaboration with the project leader and other functional group leaders for execution of all monitoring services according to the project-specific scope of work:

Define, assign, coordinate, oversee and assess utilization and productivity of the monitoring team members’ daily in-house activities according to trial-specific scope of work, budget, and timelines. Coordinate and supervise site monitoring assignments and activities, including scheduling of pre-study, initiation, periodic, and close-out site visits within visit windows and according to contractual.

• Define, assign, coordinate, oversee and assess utilization and productivity of sub-contractors including independent contract CRAs, vendor or sponsor-provided CRAs, and other contracted services.
• Provide site management and clinical monitoring expertise, and leadership to assigned team. Provide advice and guidance to team members for assessment, resolution, and documentation of site and study issues.
• Identify resource needs and supervise team members’ work assignments, utilization and productivity.
• Direct and prioritize team efforts and assess overall team progress against study timelines and metrics. Develop performance standards for project team. Identify and notify appropriate parties of emerging out of scope activities, project change orders and study guidelines. Evaluate impact on resource needs, study processes and related documents.
• Review and approve team deliverables focusing on quality and timeliness of all monitoring activities within the defined scope of work.
• Perform activities of Senior CRA as needed to move project deliverables and timelines forward.
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  Manage the development and maintenance of clinical trials documents, processes, and systems according to trial-specific scope of work and budget with minimal guidance. Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operations manual with guidance.

• Coordinate the development, use and maintenance of study-specific processes, related documents, templates and other site management, communication, monitoring and regulatory tools.
• Define site selection and activation guidelines and related activities with Investigator Relations, the project leader, the principal investigator, and the sponsor. Approve sites in collaboration with the project leader and the sponsor.
• T rain and supervise the team on trial-specific collection, review and approval of clinical trial documents and associated processes. Provide final approval of essential clinical trial documents.
• Observe for consistency in the conduct of the study and data collection according to the protocol and study objectives. Oversee identification of study and site issues and assist with resolution and documentation.
• Provide management of the development, implementation and maintenance of the clinical trial management system, related tracking tools and status reports.

• Apply best practices to site management clinical trials processes.
• Serve as key site management trial-team member to internal and external partners and to the project core team (project leader, principal investigator and other functional group key representatives).

• Collaborate with internal and external partners to develop trial- specific tools and processes, with guidance, for efficient management of tracking site and study status, enrollment, data collection, query resolution, and other trial activities.
• Provide input regarding the development of the CRF (data capture forms) design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports.
• Facilitate communication between designated internal and external contacts (including contract s, clinical supplies, pharmacy, and sponsor) and study sites. Facilitate cross-functional team communication and proactive problem solving regarding study progress and trial issues with guidance.
• Consult with Clinical Operations administration in the management of the scope of work, associated budget and timelines.
• Review and analyze site payments and associated site status against Clinical Operations budget. Consult with the financial group and contract department to facilitate re solution of study and site financial issues with guidance.
• Manage production, review and approval of trial-related reports, including site status reports, site payments, regulatory status reports, trip reports, and expense reports for internal and external dissemination. Review reports for identification and resolution of study and site issues. Notify appropriate team members of findings and action plan.
• Organize, lead, and participate in study teleconferences and meetings with the trial team and other study partners.
• Collaborate with Clinical Operations administration to identify and oversee trial-related training and performance concerns of monitoring team members according to their individual needs; maintain awareness of level of performance and training needs; provide ongoing input to Senior Clinical Trials Lead for development of individual training plan.

• Coordinate and oversee trial-specific training for CRAs which may include therapeutic in-service, reference materials, investigator meeting, team monitor training, on-site co-monitoring and training visits.
• Coordinate the coaching and training of CRA team members’. Provide and document regular feedback and coaching to individual team members. Maintain documentation, providing specific examples of performance issues.
• Facilitate participation in on-site co-monitor training visits for final sign-off of designated CRAs to perform independent site visits.
• Recognize accomplishments of individual team members and the team as a whole.
• Assist with all aspects of performance management including compiling and providing feedback to the Senior Clinical Trial Lead for team m embers’ annual performance evaluations, identifying strengths and areas for improvement using specific examples, and providing input for Individual Development Plans. Assist with development and delivery of performance reviews and work improvement plans information exchange.
• Supervise and manage monitoring trial-team members’ adherence to DCRI and sponsor-specific administrative policies with guidance. Encourage team members to attend appropriate training and meetings.

• Review trial-related expense reports, timesheets, and time-off requests for use of appropriate project and activity codes and timely completion in accordance with applicable travel guidelines and expense reporting procedures; approve and process reports.
• Oversee training and coaching of new monitoring team members on the use of applicable financial and other organizational forms for trial-specific activities, and the effective use of cost and time-saving strategies. Refer employees to Senior Clinical Trials Lead if further training or coaching is needed.
• Attend appropriate clinical team leadership meetings, department meetings and organizational meetings. Encourage team members to attend appropriate team, department and educational meetings.

• Assist in the development, implementation and revision of processes, SOPs and standard forms.
• Support the DCRI’s mission, department goals and organizational activities.

• Oversee team dynamics to foster professional relationships.
• Maintain awareness of developments in clinical research regulations and therapeutic areas by reading related literature, attendance at professional meetings and research seminars.

• Encourage and support cross-functional and therapeutic information exchange.
• Actively support the Clinical Operations functional group and the DCRI.

• Participate in special assignments as requested by project leader.
• Interview job candidates and make hire recommendations for clinical monitoring teams.
• Complete administrative activities accurately and in a timely manner, e.g., time tracking, attendance reports, training file.
  Encourage team to seek opportunities for personal development.
  Receive and review audit findings, develop action plan for audit response and provide input for formal audit response with guidance.
  
  Perform other related duties incidental to the work described herein.
  
  Preferred Education/Training:
  Bachelor’s degree in clinical, health or life science
  Preferred Education: Registered Nurse, Nurse Practitioner, Physician’s Assistant, Pharmacist
  
  Preferred Experience:
  4-5 years related clinical research experience including 3 years directly related CRA experience or clinical trial management experience
  
  Knowledge, Skills and Abilities:
  · Strong technical spelling and grammar skills, including reviewing and proof reading of business documents and communications
  · Ability to write, speak, and present strategies clearly and concisely in a variety of communication settings and styles
  · Strong interpersonal skills, ability to establish and promote positive business relationships, customer service oriented
  · Ability to collaborate with team members to achieve trial-specific goals within specified timelines
  · Ability to collaborate with internal and external partners to achieve departmental and organizational goals
  · Ability to lead others and foster teamwork; ability to manage, motivate and lead teams
  · Proficient computer skill s including MSOffice, Word, Excel and PowerPoint; able to learn and use computer applications
  · Ability to train and coach site management and clinical monitoring team members
  · Ability to direct and manage competing individual and team activities to meet trial objectives, timelines and budget
  · Ability to use critical thinking skills to effectively solve problems and use conceptual thinking to anticipate impact of decisions
  · Strong knowledge of medical terminology
  · Understanding of scientific application to clinical trials research
  · Technical knowledge and skills for monitoring procedures and practices
  · Knowledge of clinical research trial operations
  · Strong knowledge of FDA regulations, ICH guidelines, and Good Clinical Practices and their application to clinical trials
  · Understanding of departmental SOPs and systems
  · Ability to travel 25%, some for consecutive nights
  
  
  Minimum Qualifications
  
  
  Education
  Work requires graduation from an accredited degree program providing
  1. Completion of an allied health degree (e.g., Respiratory Therapy, clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus four years of healthcare experience; or one of the following equivalents: Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of six years healthcare experience; or
  2.Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or
  3. Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research; or
  4. Completion of a bachelor's degree plus a minimum of five years closely related research experience.
  
  **State of North Carolina license may be required.**
  
  Experience
  None required beyond that described above OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR 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.