Clinical Research Associate I, 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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home 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.

Position Responsibilities

Study Organization

• Perform study start-up activities for multiple sites according to the study specific plan. Assess sites’ regulatory compliance, including but not limited to informed consent review and review of investigative regulatory files.

• Manage project-specific plans for start- up activities, including distributing, and collecting essential study document packages and negotiating site contracts and study budgets within established parameters and escalating as necessary.

• 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 protocol, SOP, and regulatory/GCP deviations. Escalate findings to supervisor.

• Perform assessment of site personnel and facilities for study conduct through feasibility and site telephone qualification

• Provide guidance to designated site personnel for conducting the study in accordance with the protocol, SOPs, trial specific procedures and applicable regulations.

• 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.

Study Training

• Assist with 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.

• Escalate situations to lead CRA that may affect patient safety, data integrity or study processes and retrain site personnel accordingly.

Site Management and Monitoring

• Document routine site management and clinical monitoring activities, site communication, and trial related activities with guidance. Utilize monitoring tools and trial documents, adapting and editing standard templates as directed

• Oversee and review routine site activities for clinical trials research, with 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 guidance from experienced CRA or clinical trial lead.

• Apply knowledge of protocol and study documents and processes, during monitoring activities, in response to site activities and inquiries.

• Regularly review study and site status information and enter updates into required systems to maintain accurate, current reports

• Prepare and submit accurate and timely reports, using standard templates and forms, in accordance with SOPs and project requirements.

• Maintain essential trial and site communication record per study requirements

• Develop and implement action plans for resolution of identified site and study issues. Follow up on outstanding issues including ongoing documentation. Manage and review site data including case report form (CRF) completion and submission, data query resolution, and overall data integrity according to established processes including the Megatrials Quality by Design Guiding Principles

• Review data status reports and follow-up with sites regarding missing and/or late data.

• Provide guidance 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.

Trial Conduct

• Build and maintain effective working relationships with site personnel, and internal and external study contacts.

• Maintain appropriate professional relationships utilizing a business-like manner which fosters study compliance.

• Provide timely notification to appropriate study contacts of site status and trial related needs.

• Provide clear direction to site and trial personnel as directed 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, and sharing information.

• Provide routine updates and 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 site activities. Routinely report updates to trial supervisor without prompting.

• Follow guidance and instruction provided by senior staff member.

• Utilize supervisor as a resource for assessing findings and planning resolution of issues.

• Meet deadlines provided by supervisor. Effectively communicate obstacles that may affect deadline requirements

Administrative

• Actively support the DCRI and the Commercial Mega Trials functional group.

• Maintain job knowledge and skills through independent self-study.

• 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 feedback activities for self and others for annual performance evaluations.

• Perform other related duties incidental to the work described herein.

REQUIRED QUALIFICATIONS at this Level

Education/Training:

Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus one year of healthcare experience; or one of the following equivalents:

Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of three years healthcare experience; or

Completion of a master's degree in Public Health, Health Administration or a related area with no additional experience; or

Completion of a bachelor's degree plus a minimum of one year directly related experience in clinical trials research; or

Completion of a bachelor's degree plus a minimum of two years closely related research experience.

**State of North Carolina license may be required.**

Experience:

1 year closely related clinical research experience or 2 years clinical experience in designated therapeutic area

Preferred Experience: Clinical research associate, study coordinator, clinical trials assistant or direct patient care

OR EQUIVALENT COMBINATION OF EDUCATION AND EXPERIENCE

Required Knowledge, Skills and Abilities: Asterisk (*) distinguishes KSAs that are required at the time from those that are expected to be demonstrated at the conclusion of orientation, training, or probationary period for the position.

• * 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 communicate and work productively in a team environment

• * Strong computer skills including MS Word and Excel

• * Strong organizational skills and attention to detail

• * Ability to perform multiple activities at once to accomplish goals with competing deadlines

• * Ability to gather information for effective problem solving

• * Strong problem analysis and resolution skills

• Basic knowledge of key medical terminology

• *Basic knowledge of site management and clinical monitoring for clinical research studies

• General knowledge of Good Clinical Practices

• * Ability to travel (for traveling CRAs)

Registration, Certification or Licensure:

• Valid U.S. driver’s license

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 Qualifications

Education

Work requires graduation from an accredited degree program providing clinical training as a Registered Nurse (RN), Physician's Assistant (PA) or Pharmacist plus one year of healthcare experience; or one of the following equivalents: Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of three years healthcare experience; or Completion of a master's degree in Public Health, Health Administration or a related area with no additional experience; or Completion of a bachelor's degree plus a minimum of one year directly related experience in clinical trials research; or Completion of a bachelor's degree plus a minimum of two 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.