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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.
Occupational Summary
The DCRI Megatrials domain designs and operationalizes large global commercial clinical trials focused on evaluating new drugs/devices for regulatory approval. The team works directly with senior clinical and operational Executives at large global pharmaceutical sponsors to create a global operational plan including a protocol, risk based monitoring plan, quality data surveillance/data collection and analysis strategy to ensure patient safety and data integrity. These studies are international pivotal phase 3/phase 4 registration studies that are either for new drug approval or changes to an existing drug label. The typical DCRI Megatrial collaborates with other DCRI functional groups (i.e. project leadership, site management and monitoring, clinical events committee, data management, statistics, data and safety monitoring committee, safety surveillance) as well as multiple vendors (i.e. IVRS, drug distribution, central core lab, central ethics committee, CRO and ARO). Megatrials team members are selected based on their ability to work independently in a complex, high pressure, cross -cultural environment across multiple time zones. They are charged with delivering a high quality program according to the Megatrials Guiding Principles. These principles speak to ensuring the enrollment of the right patient who gets the right drug with complete ascertainment of safety and efficacy data according to ICH-GCP.
** 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
Study Organization
Study Training
Site Management/Monitoring
Trial Conduct
Administrative
Required Education/Training
Bachelor degree in clinical, health or life sciences.
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 or in-house site management, study coordinator, clinical trials assistant, direct patient care.
OR equivalent education and experience.
Required Knowledge, Skills and Abilities
Strong technical spelling and grammar skills
Working knowledge of medical terminology
Strong patient care knowledge in designated therapeutic area is preferred
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, internal and external partners to achieve goals
Proficient computer skills including MS Word, Excel and PowerPoint
Strong organizational skills and attention to detail
Ability to perform multiple activities 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 Good Clinical Practices
Working knowledge of site management and clinical monitoring for clinical research trials
Ability to travel 80% overnight, including consecutive nights (for traveling CRAs)
Registration, Certification or Licensure
Valid US driver's license
ACRP CCRA, CCRC or SoCRA CCRP is a plus
Working Conditions
Extensive use of email and telephone
Extensive focusing on computer monitor for long periods
Extensive repetitive keyboarding
Occasional to frequent travel with laptop and multiple business documents
Occasional lifting/moving of heavy business documents
Minimum QualificationsEducationWork 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 may be required.**
ExperienceNone 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.
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. Read more about Duke’s commitment to affirmative action and nondiscrimination at hr.duke.edu/eeo.Full Time
Scientific Services
$66k-87k (estimate)
05/14/2024
05/26/2024
dcri.org
DURHAM, NC
1,000 - 3,000
1969
ROBERT CALIFF MD
$10M - $50M
Scientific Services
As part of the Duke University School of Medicine, the Duke Clinical Research Institute (DCRI) is known globally for conducting groundbreaking multinational trials, managing major national patient registries, and performing landmark research. As an ARO, we combine the faculty expertise of practicing physicians with the full-service operational capabilities of a major CRO. We design and implement innovative clinical trials that advance the understanding of health and disease and inform efforts to improve the quality of care. Our experience stretches from phase I to phase IV and beyond, encompas...sing post-approval analyses and health economics. The breadth of our work in numerous therapeutic areas is matched by the depth of our knowledge, which we disseminate through high-impact publications and global meetings. DCRI faculty and staff have authored more than 14,000 peer-reviewed publications and have been cited in more than 619,000 scientific articles over the course of 20 years. Our 2017-2018 annual report provides a deeper look into DCRIs work. Our Culture, Our Benefits At the heart of our culture are our core valuesintegrity, excellence, respect, innovation, and teamworkthat help us define what it means to be successful both as individuals and as an organization. At the DCRI, we believe candor and collaboration promote respect and transparency and teamwork fosters a community of excellence. As a part of Duke University, DCRI employees get to take advantage of Dukes benefit plan, which has long been recognized for its comprehensiveness and competitiveness in the market. Duke benefits include outstanding medical and dental benefits; retirement plans; flexible work options; and tuition assistance. Join Us If you seek to be part of an organization that enables meaningful work where innovation thrives, we want to hear from you. For more information and to apply for open positions, please visit https://dcri.org/careers/
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