CLINICAL RESEARCH ASSOCIATE II - Onsite Monitor, DCRI*

POSITION DESCRIPTION

Onsite Clinical Research Associate II

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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 will require travel and on-site monitoring work.

Preference:

West Coast preferred

All Duke University and Duke Health 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.

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)

Preference:

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

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 may be required.**

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.