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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.

Position Summary

Provide leadership, through guidance and oversight, to the site management and monitoring team, in collaboration with the Project Leader. Manage the development, coordination, and implementation of site management and monitoring responsibilities for assigned projects, including trial-specific processes and systems. Daily supervision of the site management and monitoring team in accordance with contractual agreements, department guidelines, SOPs, applicable international, federal and state regulations, ICH guidelines, and project scope of work.

** 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, New Hampshire, Alabama, Kentucky, Louisiana, Oregon, Iowa, Missouri, Delaware, and Connecticut, Rhode Island, Vermont and Wisconsin.

Primary Responsibilities and Task

Study Organization and Oversight

Coordinate and lead site monitoring assignments and activities, ensuring the appropriate scheduling of pre-study, initiation, periodic, and close-out site visits within visit windows and according to the monitoring plan.

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.

Coordinate the development, use and maintenance of study-specific processes, related documents, templates and other site management, communication, monitoring and regulatory tools.

Coordinate with the Principal Investigators, Project Leaders and additional functional group leaders to utilize available DCRI tools to identify, classify and act upon risk indicators in support of risk-based monitoring strategies.

Define, assign, coordinate, oversee, and assess productivity of team members' daily activities according to trial-specific scope of work, budget and timelines.

Provide leadership and site management and monitoring expertise to assigned team. Provide advice and guidance to team members for assessment, resolution, and documentation of site and project issues.

Identify resource needs and escalate to Project Leader and line manager.

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 leaders of emerging out of scope activities and study guidelines. Evaluate impact on resource needs, study processes, and related documents.

Provide guidance and oversight to CRAs and sites to maintain data integrity and quality documentation.

Ensure study is set up within CTMS and provide annotated trip reports and accompanying confirmation and follow-up letter templates as applicable.

Support implementation and oversight of risk-based monitoring strategies, leveraging data-driven analysis to proactively identify and resolve quality concerns.

Provide oversight of the setup, implementation, and maintenance of assigned studies within CTMS, including tracking tools and status reports. Provide annotated trip reports and accompanying confirmation and follow-up letter templates as applicable.

Review and approve team deliverables focusing on quality and timeliness of all monitoring activities within the defined scope of work.

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

Serve as key site management trial-team members 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.

Consult with functional group leadership in the management of the scope of work, associated budget and timelines.

Organize, lead, and participate in study teleconferences and meetings with the trial team and other study partners.

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.

Oversee and participate in on-site monitoring visits to audit the quality of the performance of assigned CRAs, if necessary.

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

Participate in special assignments as requested by project leader.

Oversight of Site Management/Monitoring Team and activities

Perform site selection, feasibility, initiation, and training activities; ensure timely completion and approval of regulatory documents.

Support budget communications through site contact and escalation, as needed.

Perform activities of CRA as needed to move project deliverables and timelines forward.

Identify and report protocol, SOP, and regulatory/GCP deviations; escalate findings as needed.

Develop and implement action plans for resolution of site and study issues.

Facilitate cross-functional team communication and proactive problem-solving regarding study progress and trial issues.

Training & Mentorship

Serve as an expert resource and mentor for CRAs, providing guidance on complex issues and best practices.

Coordinate and oversee trial-specific training for project team members which may include therapeutic in-service, reference materials, investigator meeting, and team training in collaboration with the project leader and principal investigator.

Provide and document regular feedback to individual team members regarding any performance issues. Maintain documentation, providing specific examples of performance issues. Escalate as appropriate to line manager. Provide performance feedback to line manager when requested.

Provide study training and retraining to site personnel as needed to prevent compliance issues and maintain quality standards.

Maintain awareness of developments in clinical research regulations and therapeutic areas by reading related literature, attending professional meetings and research seminars.

Recognize accomplishments of individual team members and the team.

Oversee team dynamics to foster professional relationships.

Regulatory Compliance

Serve as an expert resource for site regulatory matters, providing guidance on complex compliance issues.

Develop and implement corrective action plans for regulatory and SOP deviations. Support site management team in implementation of corrective action plans.

Assist CRAs in preparation for site-level audits or internal DCRI inspections.

Receive and review audit findings, develop action plans for audit response and provide input for formal audit response with guidance.

Provide guidance to site personnel on documentation standards, CRF completion, data procedures, and query resolution.

Assess protocol and regulatory compliance, including source document verification, human subject protection, data integrity, and drug accountability.

Review patient data and source documents to verify compliance and data integrity.

Stakeholder Communication

Build and maintain effective relationships with site personnel, internal teams, and external study contacts to support performance and foster study compliance, including at challenging sites.

Provide timely updates and clear direction to external study contacts regarding site status and trial needs, and routinely report progress to internal stakeholders, escalating complex issues as appropriate.

Contribute to positive team dynamics through effective communication and collaboration.

Contribute to department initiatives and represent the department for complex or cross-functional projects; provide subject matter expertise and contribute to process improvements.

Perform other related tasks incidental to the work described herein.

Required Qualifications

 

Education/Training: (refer to the Duke HR website for minimum qualifications required if applicable)

Work requires graduation from an accredited degree program providing 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:

1. Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or associate's 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: (refer to the Duke HR website for minimum qualifications required if applicable)

None required beyond that described above

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

This position requires the ability to travel to support on-site monitoring and study-related activities.

Minimum QualificationsEducation

Work requires graduation from an accredited degree program providing 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: 1. 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 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

Degrees, Licensures, Certifications

None required beyond that described above OR ANEQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE