Director, Clinical Research Content

Location
Duarte, California
Salary
Competitive
Posted
August 09 2019
Ref
10003604
Position Type
Full Time
Organization Type
Healthcare/Hospital
About City of Hope

City of Hope, an innovative biomedical research, treatment and educational institution with over 6,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.

Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nation's leading cancer centers that develops and institutes standards of care for cancer treatment.

Position Summary

Under the direction of the Senior Director, Clinical Research Services, 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, and related Electronic Health Record (EHR) functionality under the jurisdiction of Research Operations. This is a key leadership position and instrumental to the successful conduct of clinical research studies as managed within the Epic EHR. In this role, 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 IT build teams. Incumbent must ensure alignment of work in conjunction with the OnCore Clinical Trials Management System (CTMS) program goals, and must ensure efficient and effective integration between EHR and CTMS platforms.

The Director 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, Beaker lab content, Adverse Event note templates, Orders content, and additional EHR features that arise through upgrades. S/he 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 will also, in collaboration with their direct supervisor as well as the Senior Vice President of Research Operations, 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.

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 (Beacon protocols and other Epic features), 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 the Clinical Research Content workload is well integrated into the City of Hope study activation process effectively and without disruption to enterprise study activation timeline targets. The Director is responsible for the hiring, training and discipline of all staff, including on-boarding new employees and the development and upkeep of all training curricula. This individual will also utilize their comprehensive knowledge of therapeutic clinical research studies to develop study-specific content for an apportioned workload as part of the team.

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 may also be required to 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:

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 Protocol content and Adverse Event 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. Also monitors 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.

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 Research Content team's work product supports the integrated research workflows within the electronic health record.

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.

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.

Maintains current knowledge, skills and competencies through involvement in professional continuing education activities as needed. This may include Epic training and certifications as required by departmental needs. Willingness to travel as necessary to complete and maintain appropriate training.

Adheres to all professional and regulatory standards. Complies with all applicable regulations and company policies; ensures that work is performed in a safe and compliant manner; completes all required training on time and maintains proper records in accordance with SOPs and policies

Basic education, experience and skills required for consideration:
  • Current RN License, BSN required OR Graduate of an ACPE-accredited School of Pharmacy with a Pharm D.
  • Minimum of five years of supervisory experience.
  • Minimum 5-8 years of experience with progressively increasing responsibilities as an RN, Clinical Research related to clinical trials, or Pharmacist working in an academic environment, or equivalent combination of education and clinical research experience.
  • Strong working knowledge of policies and procedures related to conduct of clinical research, applicable regulatory requirements governing clinical research, and familiarity with the standard scope of practice for the research pharmacist and clinical research nursing roles.
  • Familiarity with oncology clinical practice and relevant workflows, including an understanding of scheduling, lab, radiology, and drug ordering.
  • Excellent oral/written communication, with the ability to discuss and convey technical information/processes to all organizational stakeholders clearly and concisely. Strong organizational skills, attention to detail, accuracy, and the ability to work in a team environment. Effective leadership skills and strong client oriented service skills.
  • Able to effectively multi-task and manage multiple, complex projects on schedule. Ability to review project deliverables for completeness, quality and compliance with established project standards.
  • Self-motivated, independent and possesses the ability to learn quickly.
  • Able to successfully negotiate and collaborate with others of different skill sets, backgrounds and levels within and external to the organization.
  • Epic, Microsoft Office Word, Excel, Outlook


Required Certification/Licensure:
  • Current Pharmacist License OR current RN License.


Preferred education experience and skills:
  • OCN preferred.
  • Epic certification(s) preferably Beacon, Research, and 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 either a clinical research RN OR clinical research pharmacist preferred.


City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.

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