Work Arrangement: 

Requisition Number:  249090

Regular or Temporary:  Regular

Location:  Durham, NC, US, 27710

Personnel Area:  MEDICAL CENTER

Date:  Aug 20, 2024

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.

MegaTrials CRA Lead (Job Code 2985) 

Position Summary

Manage the development, coordination and implementation of clinical operations site management and clinical monitoring responsibilities for assigned projects with guidance, including trial-specific processes and systems, and daily supervision of the Mega Trial team responsible for site management and clinical monitoring in accordance with contractual agreements, department guidelines, SOPs, applicable international, federal and state regulations, and ICH guidelines.

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

Core Job Responsibilities

1. Provide leadership for the Mega Trial project team responsible for site management working in close collaboration with the project leader and other functional group leaders for execution of all monitoring services according to the project-specific scope of work:

• Define, assign, coordinate, oversee and assess utilization and productivity of team members’ daily in-house activities according to trial-specific scope of work, budget, and timelines.

Define, assign, coordinate, oversee and assess utilization and productivity of sub-contractors including independent contract CRAs, vendor or sponsor-provided CRAs, and other contracted services.

• Provide site management and clinical monitoring expertise, and leadership to assigned team. Provide advice and guidance to team members for assessment, resolution, and documentation of site and project issues.
• Identify resource needs and supervise team members’ work assignments, utilization and productivity.
• Direct and prioritize team efforts and assess overall team progress against project timelines and metrics. Develop performance standards for project team. Identify and notify project leader of emerging out of scope activities and study guidelines. Evaluate impact on resource needs, study processes and related documents.
• Review and approve team deliverables focusing on quality and timeliness of all activities within the defined scope of work.
• Oversight, and management of the Mega Trials SONAR report for each trial including ARO SONAR report when applicable.

1. Manage the development and maintenance of clinical trials documents, processes, and systems according to trial-specific scope of work and budget with minimal guidance. Participate in the development of the protocol, protocol revisions and amendments, monitoring plan, scope of work and operations manual with guidance.

• Coordinate the development, use and maintenance of study-specific processes, related documents, templates and other site management, communication, monitoring and regulatory tools.
• Define site selection and activation guidelines and related activities with the project leader, the principal investigator, and the sponsor. Approve sites in collaboration with the project leader and the sponsor.
• Train and supervise the team on trial-specific collection, review and approval of clinical trial documents and associated processes. Provide final approval of essential clinical trial documents.
• Observe for consistency in the conduct of the study and data collection according to the protocol and study objectives. Oversee identification of study and site issues and assist with resolution and documentation.
• Provide management of the development, implementation and maintenance of the clinical trial management system, related tracking tools and status reports.
• Apply best practices to site management clinical trials processes.

1. Serve as key site management trial-team member to internal and external partners and to the project core team (project leader, principal investigator and other functional group key representatives).

• Collaborate with internal and external partners to develop trial-specific tools and processes, with guidance, for efficient management of tracking site and study status, enrollment, data collection, query resolution, and other trial activities.
• Provide input regarding the development of the CRF (data capture forms) design and completion instructions, site materials, query rules and resolution process, and related data tools and status reports.
• Facilitate communication between designated internal and external contacts (including contracts, clinical supplies, pharmacy, and sponsor) and study sites. Facilitate cross-functional team communication and proactive problem solving regarding study progress and trial issues with guidance.
• Manage production, review and approval of trial-related reports, including site status reports, site payments, regulatory status reports, trip reports, and expense reports for internal and external dissemination. Review reports for identification and resolution of study and site issues. Notify appropriate team members of findings and action plan.
• Organize, lead, and participate in study teleconferences and meetings with the trial team and other study partners

1. Coordinate and oversee trial-specific training for project team members which may include therapeutic in-service, reference materials, investigator meeting, and team training, Provide and document regular feedback to individual team members. Maintain documentation, providing specific examples of performance issues.

• Recognize accomplishments of individual team members and the team as a whole.
• Manage all aspects of performance management including compiling and providing feedback to the team members’ annual performance evaluations, identifying strengths and areas for improvement using specific examples, and providing input for Individual Development Plans. Assist with development and delivery of performance reviews and work improvement plans.
• information exchange

1. Attend appropriate Mega Trial leadership meetings, department meetings and organizational meetings. Encourage team members to attend appropriate team, department and educational meetings.

• Assist in the development, implementation and revision of processes, SOPs and standard forms.

1. Support the DCRI’s mission, department goals and organizational activities.

• Oversee team dynamics to foster professional relationships.
• Maintain awareness of developments in clinical research regulations and therapeutic areas by reading related literature, attendance at professional meetings and research seminars.
• Encourage and support cross-functional and therapeutic information exchange.

1. Actively support the Mega Trial functional group and the DCRI.

• Participate in special assignments as requested by project leader.
• Interview job candidates and make hire recommendations for teams.
• Complete administrative activities accurately and in a timely manner, e.g., time tracking, attendance reports, training file.
• Encourage team to seek opportunities for personal development.
• Receive and review audit findings, develop action plan for audit response and provide input for formal audit response with guidance.
• Perform other related duties incidental to the work described herein

Education/Training

Bachelor’s degree preferable in clinical, health or life science.

Experience

Four years directly related experience in clinical trials research or 5 years four years directly related experience in clinical trials research. Prefer 3 years directly related CRA or clinical trial management experience.

OR   AN   EQUIVALENT   COMBINATION   OF        RELEVANT                 EDUCATION         AND/OR EXPERIENCE

Required Knowledge, Skills and Abilities

Asterisk (*) or other notation to distinguish 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, including reviewing and proof reading of business documents and communications
• Ability to write, speak, and present strategies 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 team members to achieve trial-specific goals within specified timelines
• Ability to collaborate with internal and external partners to achieve departmental and organizational goals
• Ability to lead others and foster teamwork; ability to manage, motivate and lead teams
• Proficient computer skills including MS Office, Word, Excel and PowerPoint; able to learn and use computer applications
• Ability to train and coach site management and clinical monitoring team members
• Ability to direct and manage competing individual and team activities to meet trial objectives, timelines and budget
• Ability to use critical thinking skills to effectively solve problems and use conceptual thinking to anticipate impact of decisions
• Strong knowledge of medical terminology
• Understanding of scientific application to clinical trials research
• Technical knowledge and skills for monitoring procedures and practices
• Knowledge of clinical research trial operations
• Strong knowledge of FDA regulations, ICH guidelines, and Good Clinical Practices and their application to clinical trials
• Understanding of departmental SOPs and systems
• Ability to travel 25%, some for consecutive nights

Registration, Certification or Licensure

• Valid U.S. driver’s license
• ACRP CCRC or CCRA, 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
• Occasional travel with a laptop computer and heavy business documents

Education/Training

Bachelor’s degree pre ferable in clinical, health or life science.

Experience

Four years directly related experience in clinical trials research or 5 years four years directly related experie nce in clinical trials research. Prefer 3 yea rs directly related CRA or clinical trial management experience.

OR   AN   EQUIVALENT   COMBINATION   OF   RELEVANT        EDUCATION               AND/OR EXPER IENCE

Required Knowledge, Skills and Abilities

Asterisk (*) or other notation to distinguish 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, including revi ewing and proof reading of business documents and communications
• Ability to write,< span>speak, and present s trategies clearly and concisely in a variety of commu nication settings and styles
• Strong interpersonal skills, abili ty to establish and promote positive business relationships , customer service oriented
• Ability to collaborate with team memb ers to achieve trial-specific goals within specified timeli nes

Minimum Qualifications

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 four 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 six years healthcare experience; or 2.Completion of a master's degree in Public Health, Health Administration or a related area with three years directly related clinical trials research experience; or 3. Completion of a bachelor's degree plus a minimum of four years directly related experience in clinical trials research; or 4. Completion of a bachelor's degree plus a minimum of five 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.

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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.