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 moderately complex on-site and in-house site assessments independently for clinical trials research. Perform complex on-site and in-house site assessments with direction. Use critical thinking skills to monitor sites' compliance with study, sponsor, organizational, and government guidelines. Collect, document, update, and report study information according to procedures and timelines. Create new and customize existing templates and processes to meet project needs with some direction. Follow up, resolve, and report on issues identified during study monitoring and assessment activities with minimal to no direction.

Position Summary:

Perform routine and moderately complex on-site and in-house site assessments independently for clinical trials research. Perform complex on-site and in-house site assessments with direction. Use critical thinking skills to monitor sites' compliance with study, sponsor, organizational, and government guidelines. Collect, document, update, and report study information according to procedures and timelines. Create new and customize existing templates and processes to meet project needs with some direction. Follow up, resolve, and report on issues identified during study monitoring and assessment activities with minimal to no direction.

** 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

Primary Responsibilities and Tasks:

• Oversee and review routine and moderately complex site activities, with minimal to no guidance, 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 protocol, regulatory, and SOP compliance with some guidance from an experienced CRA or a clinical trial lead.
• May travel up to 80% to perform on-site monitoring visits, including site selection, initiation, periodic, and close out visits. Perform or assist with unexpected site visits as directed. Schedule site visits according to DCRI travel policy and trial-specific guidelines while effectively using cost and time saving efficiencies.
• Independently perform monitoring activities for multiple sites and possibly multiple projects, identifying and reporting deviations from regulations and SOPs. 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 studies in accordance with the protocol, SOPs, trial specific procedures and applicable regulations. Identify situations that may affect subject safety or data integrity and retrain site personnel accordingly.
• 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. Recognize ongoing action items and coach site personnel to improve their performance.
• Assist sites with preparation for planned and unannounced audits with some guidance.
• Perform trial supervisory activities as directed by trial project leader with approval of line manager.

• Independently document routine site management and clinical monitoring activities, site communication, and trial related activities. Document complex site management and clinical monitoring activities, site communication, and trial related activities with minimal to no guidance. Utilize monitoring tools and trial documents, recommend revisions to improve efficiencies of monitoring tools, trial documents, and study processes; independently develop study-specific versions as directed.
• 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 3% spelling and grammatical errors. Prepare and submit accurate and timely confirmation letters, monitoring reports, follow-up letters and expense reports, using standard templates and forms, in accordance with SOPs and project requirements. Assist trial supervisor with review of monitoring visit documentation for other team members.
• Maintain essential trial and site communication records, electronic and hard copy, removing non-essential communication to meet trial and organizational and government standards as directed.
• Develop and implement action plans for resolution of routine and complex site and study issues. Follow up on outstanding issues including ongoing documentation.

• Manage and review routing and moderately complex site data including case report form (CRF) completion and submission, data query resolution, and overall data integrity according to established practices, with minimal to no guidance. Recommend improvements for data collection and data processing and implement efficiencies as directed.
• Review specified 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 coach sites to improve 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.

• Build and maintain effective working relationships with site personnel, internal and external study contacts. Promote confidence in the Government Trials & Network functional group and the DCRI.
• Maintain appropriate professional relationships utilizing an assertive, business-like manner which fosters study compliance. Develop effective working relationships with difficult sites.
• 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 professionally 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 trial-specific activities, working with trial team members as directed by the trial supervisor.

• Provide routine updates and moderately 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 with minimal to no guidance.
• 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 recommend resolution of complex issues, utilizing trial supervisor as a resource to verify proposed plans.

• Serve as a resource to other team members for day-to-day trial activities. Participate as a trainer and mentor for subordinates, peers, and site personnel.
• Assist with training less experienced Clin.Ops. personnel for routine on-site monitoring visits and in-house monitoring activities. Document training activities with minimal to no guidance.
• Develop site training 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 Government Trials & Network functional group.
• 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, attendance reports, training file.

• Attend functional group meetings.
• Participate in 360 feedback activities for self and others for annual performance evaluations.
• Participate in special assignments as requested by supervisors.
• Perform other related duties incidental to the work described herein.

Required Education/Training:

Bachelor's degree in clinical, health or life science

Preferred Education: Registered Nurse, Nurse Practitioner, Physician's Assistant, Pharmacist

Required Experience:

2 years directly related clinical research experience

Preferred Experience: CRA who has independently performed multiple on-site monitoring visits, study coordinator, clinical trials assistant; direct patient care

OR equivalent education and experience

Required Knowledge, Skills and Abilities:

• Strong technical spelling and grammar skills;
• 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
• Proficient computer skills including MS Word and Excel
• Strong organizational skills and attention to detail
• Ability to perform multiple activities at once to accomplish individual and team goals with competing deadlines
• Strong problem analysis and resolution skills
• Ability to perform routine site management and monitoring activities independently
• Working knowledge of medical terminology
• Strong patient care knowledge in designated therapeutic area is preferred
• Working knowledge of site management and clinical monitoring for clinical research trials
• Working knowledge of Good Clinical Practices
• 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 heavy business documents

Minimum Requirements

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 two 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 four years healthcare experience; or 2.Completion of a master's degree in Public Health,., Health Administration or a related area with. one year directly related clinical trials research experience; or 3. Completion of a bachelor's degree plus a Minimum of two years directly related experience in clinical trials research; or 4. Completion of a bachelor's degree plus a minimum of three years closely related research experience. **State of North Carolina license maybe 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.