School of Medicine

Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.
Position Summary:
Perform routine and complex on-site and in-house site assessments for clinical trials research independently. Organize and prioritize time to complete concurrent assignments on multiple trials. Use critical thinking skills to monitor sites' compliance with study, sponsor, organizational, and government guidelines. Independently create new and customize existing templates to meet project needs. Collect, document, update, and report study information according to project-specific scope of work and timelines. Critically assess trial processes, anticipate problems, and recommend improvements. Follow up, resolve, and report on complex issues identified during study monitoring and assessment activities.
** NOTE: This position may have an opportunity to work remotely. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut
Position Responsibilities & Key Tasks
1. Independently oversee and review routine and complex site activities, through monitoring activities, including on-site visits and/or in-house assessments, including telephone contact, and other technologies according to the trial-specific monitoring plan to assess study progress and protocol, regulatory, and SOP compliance.
•May travel up to 80% to perform all types of routine, unexpected, and complex on-site monitoring visits. Schedule site visits according to DCRI travel policy and trial-specific guidelines maximizing cost and time saving efficiencies.
•Independently perform site monitoring activities for multiple sites and multiple and complex projects, identifying and reporting deviations from regulations and SOPs. Critically assess protocol and regulatory compliance, including but not limited to, source document verification, informed consent process and human subject protection, data integrity, drug accountability and compliance, and review of investigator and regulatory files.
•Assess adequacy of site personnel and facilities for study conduct.
•Provide study training and guidance to designated site personnel for conducting the study in accordance with the protocol, SOPs, trial specific procedures and applicable regulations. Anticipate potential situations that may affect subject safety or data processes and retrain site personnel to prevent issues.
•Identify action items and discuss with appropriate site personnel. Communicate routine and unusual findings to trial supervisor. Document ongoing follow-up and resolution of issues.
•Assist sites with preparation for audits.
•Perform trial supervisory activities as directed by trial manager with approval of line manager.
•Critically assess each site's ongoing activities and continuously coach them to improve their clinical research practices for DCRI trials.
•Serve as senior and/or sole Site Management & Clinical Monitoring study team member.
2. Independently document routine and complex site management and clinical monitoring activities, site communication, and trial related activities. Recommend revisions improve efficiencies of monitoring tools, trial documents, and study processes; independently develop and implement study-specific versions.
•Apply knowledge of protocol and study documents and processes, during monitoring activities, including on-site visits and in-house assessments, in response to site activities and inquiries.
•Regularly review and update study and site status information into required systems to maintain accurate, current reports.
•Independently prepare monitoring reports for multiple sites and projects with no more than 1% spelling and grammatical errors. Prepare and submit accurate and timely confirmation letters, monitoring reports, follow-up letters and expense reports, in accordance with SOPs and project requirements. Review monitoring visit documentation for other team members.
•Maintain essential trial and site communication records, electronic and hard copy, removing non-essential communication to meet organizational and government standards and recommendations.
•Develop and implement action plans for resolution of routine and complex site and study issues. Follow up on outstanding issues including ongoing documentation.
3. Independently manage and review routine and complex data and data systems, including case report form (CFR) completion and submission, data query resolution, and overall data integrity according to established practices. Develop and implement improvements for data collection and data processing.
•Review patient data and source documents. Appropriately report safety concerns, protocol deviations or unexpected data trends.
•Review data status reports and follow-up with sites regarding missing and/or late data. Observe for trends and proactively train sites for optimal performance.
•Provide training for site personnel on appropriate source documentation, CRF completion, data procedures and timelines, and query resolution. Review data queries, assist sites with query resolution and follow up on outstanding queries.
4. Build and maintain effective working relationships with site personnel and internal and external study contacts. Promote loyalty to DCRI through expert clinical research and good clinical practices.
•Maintain appropriate professional relationships utilizing an assertive, business-like manner which fosters study compliance. Develop effective working relationships with difficult sites and other study contacts.
•Provide timely notification to appropriate study contacts of site status and trial related needs.
•Provide clear direction to site and trial personnel on all aspects of the clinical trial while following project guidelines and representing the DCRI and the DCRI's clients.
•Contribute to positive team dynamics through effective listening and verbal communication including active participation in team meetings, interaction with team members, sharing information, and proactive problem identification and resolution.
•Act as the point person for routine and complex trial-specific activities, working collaboratively with trial team members.
5. Independently provide routine updates and complex reports to trial supervisor(s) and other assigned contacts to ensure timely communication regarding status of sites, study issues and resolutions, and trial activities.
•Communicate with teammates to consolidate accurate and complete assessments of sites' activities. Routinely report updates to trial supervisor without prompting.
•Routinely communicate with internal partners as needed for trial activities.
•Independently assess findings and resolve complex issues.
6. Serve as an expert resource for CRAs and other team members. Independently train and mentor subordinates, peers, and site personnel.
•Train less experienced Site Management & Clinical Monitoring personnel for all types and complexities of monitoring activities and assessments including regulatory and other document activities.
•Develop and implement site training plans and materials, including site initiation activities, agendas, slides, and study tools.
•Provide scientific and technical training to team members based on areas of individual expertise.
Other Duties

• • Maintain job knowledge and skills through independent self-study.
  • Actively support the DCRI and the Site Management & Clinical Monitoring department.
  • Review education and training experience with line manager and complete identified training needs within designated time period.
  • Complete administrative activities accurately and in a timely manner, e.g., time tracking entries and approvals, attendance reports, training file.
  • Attend department meetings.
  • Participate in 360 feedback activities for self and others for annual performance evaluations.
  • Lead and participate in special assignments as requested by supervisors.
  • Interview job candidates and make hire recommendations for site management and monitoring teams.
  • Represent the Site Management & Clinical Monitoring group for department initiatives or special projects.
  • Contribute to therapeutic initiatives as directed.
  • Perform other related duties incidental to the work described herein.

Required Education/Training:
4 year degree in clinical, health or life science
Preferred Education: Registered Nurse, Nurse Practitioner, Physician's Assistant, Pharmacist
Required Experience:

• 4-5 years related clinical research experience including 3 years directly related CRA experience

Preferred Experience: Direct patient care, study coordinator

• Or Equivalent education and experience

Required Knowledge, Skills and Abilities:
•Strong technical spelling and grammar skills, including review and proof reading of business documents
•Ability to write and speak 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 study staff and internal and external partners to achieve goals
•Strong computer skills MS including MS Word and Excel
•Excellent organizational skills and attention to detail
•Ability to manage and direct several activities concurrently with competing goals and deadlines
•Ability to work independently with minimal to no upward direction to perform multiple complex site management and clinical monitoring activities and achieve trial-specific goals within specified timelines
•Strong knowledge of medical terminology
•Strong focused therapeutic or cross-therapeutic knowledge
•Strong knowledge of clinical research trial processes including site management
•Expert clinical monitoring skills
•Strong knowledge of FDA regulations, ICH guidelines, and Good Clinical Practices and their application to clinical trials
•Ability to travel 80% overnight, including consecutive nights (for traveling CRAs)
Registration, Certification or Licensure:
•Valid U.S. driver's license
•ACRP CCRC or SoCRA CCRP is a plus
Working Conditions:

• Extensive use of telephone and electronic mail systems
• Extensive repetitive keyboarding motions
• Extensive focusing on computer monitor for long periods of time
• Occasional lifting and moving of business documents
• Frequent traveling with a laptop computer and business documents

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 three 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 five years healthcare experience; or 2.Completion of a master's degree in Public Health,., Health Administration or a related area with. two years directly related clinical trials research experience; or 3. Completion of a bachelor's degree plus a Minimum of three years directly related experience in clinical trials research; or 4. Completion of a bachelor's degree plus a minimum of four 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.