Director, Clinical Research Content

Position Summary

Under the direction of the Executive Director, Research Applications & Data Management, the Director, Clinical Research Content is responsible for the conduct, oversight and administration of all work related to the creation, implementation and maintenance of ConnectHope Beacon protocols, treatment plans, Research Toxicity Assessments, and other aspects related to orders and procedures in the Electronic Health Record (EHR) for clinical trials. In this role, the Director will oversee all research content across the City of Hope (COH) network and will be responsible for ensuring consistent quality and content across all network sites. The Director, Clinical Research Content will provide consistent leadership and direction to the Clinical Research Content Development team to ensure adherence to high-quality, standardized work practices, streamlined interdepartmental communication and effective collaboration with leadership and staff across multiple departments, including the Clinical Trials Office, Clinical Trials Support Services, Investigational Drug Services Administration and the EHR build teams. Incumbent must ensure alignment of work in conjunction with the CTMS program goals and must ensure efficient and effective integration between EHR and CTMS systems.
The Director, Clinical Research Content will oversee and participate in the development of clear, timely and comprehensive protocol-specific EHR content for all clinical research studies, including Beacon protocol content, applicable order sets, and Research Toxicity Assessment templates. The incumbent will provide department-specific support and accountability to ensure all research-related content in the EHR is accurate and up-to-date for both new and ongoing clinical research studies. This includes the establishment and maintenance of high-quality work standards and transparent workflows that support timely study activation and study amendment compliance. The Director, Clinical Research Content will also establish departmental performance metrics to measure quality and productivity on behalf of their team and will be responsible for routine monitoring and reporting of this data to leadership. In partnership with the VP, Network Clinical Research Operations, develop processes to support the expansion and standardization of research content across the COH network.
Responsibilities for this position include, but are not limited to, day-to-day oversight of the Clinical Research Content Development team, delineation of roles, responsibilities and workloads within the team; policy development and maintenance; troubleshooting workflows, EHR content design (including both Beacon PRL's and applicable order sets), construction, validation, testing and optimization, study-content and/or technical challenges triage; and actively ensuring that all work product meets departmental expectations for both quality, compliance, and volume. The incumbent will ensure Clinical Research Content Development is integrated into the City of Hope study activation process effectively and without disruption to enterprise study activation timeline targets. The Director, Clinical Research Content is responsible for the hiring, training and management of all content administration staff, including on-boarding new employees and the development and upkeep of all training curricula.
The incumbent will be expected to demonstrate strong leadership skills to model, motivate and monitor their team performance to support clinical consistency and provide superior quality service and customer service excellence. The incumbent must have, obtain and maintain currency of relevant EPIC training certifications, including but not limited to EPIC Beacon, Research, and Willow certifications, as applicable.

Key Responsibilities include:

• Clinical Research Content Leadership
• Serves as the EHR Clinical Research Content Team leader, working in collaboration with Principal Investigators, Disease/Modality Teams and Study Teams to oversee the development of comprehensive protocol-specific content (including, but not limited to, Beacon PRL content, applicable order sets, and Research Toxicity Assessment templates, for the clinical research portfolio.
• Provides day-to-day oversight of the content development team including delineation of responsibilities, disease team assignments, workload prioritization and productivity monitoring.
• Develop and maintain comprehensive standard operating procedures (SOPs) to ensure consistency and compliance of work product, while also monitoring work product for quality and consistency and provides training as required.
• Uses independent critical judgment as needed to troubleshoot unexpected challenges and escalates as appropriate.
• Assists team members in navigating competing priorities to ensure that work product and output are consistent with the strategic goals of the institution.
• Where appropriate, develop network specific processes to support of COH network sites.
• Department Management
• Coordinates across multiple disciplines to develop and implement departmental policies, standards of practice, work standardization, and guidance / training that are clear, comprehensive and in keeping with City of Hope standard operating procedure.
• Ensures that the Clinical Trial Content Development Team's work product supports the integrated research workflows within the electronic health record.
• Process Management
• Develops and maintains transparent and effective workflows to support timely study activation and study amendment compliance.
• Ensures consistent and reliable tracking and status of all projects, from assignment through completion.
• Develops and monitors status reports and productivity metrics with management and peers as appropriate.
• Proactively communicates challenges and escalates appropriately to ensure that projects are completed in a timely manner.
• Personnel Management
• Recruits, trains, evaluates, and disciplines staff as needed.
• Manages employee work schedules and assignments to ensure adequate coverage.
• Assists with developing performance goals and objectives.
• Works with direct reports to resolve personnel issues.
• Supports staff training and development.
• Performs other related duties as assigned or requested.

Basic education, experience and skills required for consideration:

• Graduate of an ACPE-accredited School of Pharmacy with a Pharm D
• Minimum of five years of supervisory experience. Minimum 5-8 years' experience with progressively increasing responsibilities as a Pharmacist working in an academic environment, or equivalent combination of education and clinical research experience.

Required Certification/Licensure:

• Current Pharmacist License

Preferred education experience and skills:

• EPIC certification(s) - preferably Beacon, Research, or Willow
• EPIC Beacon Build Experience, preferably at least 1 year
• Familiarity with EPIC and the delivery of care within the EPIC environment
• Previous experience as clinical research pharmacist preferred

Additional Information:

• As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.