CLINICAL RESEARCH ASSOCIATE II, DCRI

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, Indiana, Michigan, Maine, Ohio and New Hampshire.

Preferences:

Midwest candidates due to travel and on-site requirements of this role.

Position Responsibilities

Study Organization

• Assess adequacy of site personnel and facilities for study conduct.
• Work closely with study sites to complete study start-up by facilitating site regulatory document completion, regulatory approval and readiness to participate.
• Negotiate and complete contract process.

Study Training

• Provide initial and ongoing study training and guidance to designated site personnel for conducting study in accordance with protocol, SOPs, trial specific procedures and applicable regulations via Investigator meetings, WebEx, telephone and email.
• Identify situations that may affect patient safety, data integrity or study processes and retrain site personnel accordingly.

Site Management/Monitoring

• Perform routine and complex on-site and in-house site assessment for approximately 30-50 clinical sites with minimal to no guidance. Act as primary study contact and guide site through study procedures.
• Review and approve site-specific Informed Consent Form templates.
• Manage and oversee continuing regulatory, contract completion and trial process work by CRA 1 through trial close-out.
• Independently 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.
• Identify and report deviations from protocol, regulations and SOPs.
• Identify action items and discuss with appropriate site personnel. Document ongoing follow-up and resolution. Coach site personnel to improve performance.
• Identify when issues require escalation. Implement and work with sites on corrective action plans to address compliance issues.
• Oversee and ensure distribution of appropriate forms, supplies, equipment and investigational product and receipt by site according to established trial timelines.
• Regularly review and update study and site status information into required systems to maintain accurate, current reports.
• Routinely communicate study expectations and progress with sites.
• Document essential trial site management and monitoring activities and site communication, electronic and hard copy, 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.
• Work with sites to ensure data collection, entry and cleaning are complete, and that benchmarks/timelines for completion are maintained with minimal to no guidance. Provide training, assistance and follow up for appropriate query resolution and source documentation. Review data status reports to observe trends and progress.
• Use knowledge of protocol to interpret data and work with other functional groups and sites to resolve clinical data issues.

Trial Conduct

• Build and maintain effective working relationships with site personnel, internal and external study contacts by utilizing an assertive, business-like manner which fosters study compliance and promotes confidence in DCRI.
• Contribute to positive team dynamics through effective listening and communication, sharing information and proactively identifying problems and resolutions.
• Routinely communicate with internal partners as needed for trial activities.
• Act as point person for trial-specific activities. Participate in special assignments as requested by supervisors.
• Provide routine and complex reports to ensure timely communication regarding status of sites, study issues and resolutions, and trial activities, with minimal to no guidance.
• Serve as mentor/coach for all assigned CRA 1 and Clinical Trial Assistant (CTA) personnel, and provide input for performance evaluations.
• Serve as resource to other team members for day-to-day trial activities. Participate as trainer and mentor.
• Develop training materials and study tools.

Administrative

• Maintain job knowledge and skills through required, recommended and independent ongoing study and training.
• Attend team, functional group and DCRI meetings.
• Complete administrative activities accurately and in a timely manner; e.g., time tracking, training file.
• Participate in feedback activities for self and others for annual performance evaluations.

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)

West Coast preferred

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

Duke is an Affirmative Action/Equal Opportunity Employer committed toproviding employment opportunity without regard to an indiv idual's age,color, disability, gender, gender expression, gender identit y, geneticinformation, national origin, race, religion, sex, sexual orie ntation,or veteran status.

Duke aspires to create a c ommunity built on collaboration,innovation, creativity, and belonging. O ur collective success depends onthe robust exchange of ideas-an exchange that is best when the richdiversity of our perspectives, backgrounds, a nd experiences flourishes.To achieve this exchange, it is essential that all members of thecommunity feel secure and welcome, that the contribut ions of allindividuals are respected, and that all voices are heard. All members ofour community have a responsibility to uphold these values.

Duke U niversity provides an annual base salary range for thisposition as USD $ 75,568.00 to USD $122,103.00. Duke University considersfactors such as ( but not limited to) scope and responsibilities of theposition; candidate 's work experience, education/training, and keyskills; internal peer equ ity; as well as market and organizationalconsiderations when extending a n offer.

Your total compensation goes beyond the dollars on your paycheck.Duke provides comprehensive and competitive medical and de ntal careprograms, generous retirementbenefits, and a wide array of fam ily-friendly and cultural programs to eligible team members. Learn more at:https://hr.duke.edu/benefits/

Essential Physical Job F unctions: Certain jobs at Duke University andDuke University Health Syst em may include essential job functions thatrequire specific physical and /or mental abilities. Additionalinformation and provision for requests f or reasonable accommodation willbe provided by each hiring department.

Work requires graduation f rom. an accredited degree program providingclinical training as a Regist ered Nurse (RN), Physician's Assistant(PA) or Pharmacist plus two years of healthcare experience; or one ofthe following equivalents:1. Completi on of an allied health degree (e.g., Respiratory Therapy,Radiologic Tech nology, Licensed Practical Nurse) or Associates degree inClinical Trials Research related curriculum plus a minimum offour yearshealthcare exper ience; or2.Completion of a master's degree in Public Health,., HealthAdm inistration or a related area with. one year directly relatedclinical tr ials research experience; or3. Completion of a bachelor's degree plus a Minimum of two yearsdirectly related experience in clinical trials resea rch; or4. Completion of a bachelor's degree plus a minimum of three year sclosely related research experience.**State of North Carolina license m ay be required.**

None required beyond tha t 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.