Senior Protocol Content Administrator
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.
The Protocol Content Administrator (PCA) reports directly to the Director, Clinical Research Content. S/he is part of a team dedicated to working collaboratively with Physicians, Clinical Research Nurses, Clinical Research Nurse Leaders, Clinical Research Coordinators, Investigational Drug Pharmacists and the Epic (Beacon) build team in support of clinical research trials conducted at City of Hope. The Protocol Content Administrator, in collaboration with Principal Investigators and the Disease/Modality-specific Study Teams, will have primary responsibility for the clinical research content development and maintenance of all therapeutic and interventional study protocols that will guide the Beacon and Willow build as part of the Epic Electronic Health Record (EHR) and integration with OnCore Clinical Trials Management System (CTMS).
The Protocol Content Administrator will use comprehensive knowledge of clinical research studies to develop clear, timely and comprehensive protocol-specific content, (including but not limited to detailed delivery instructions for all required pre-medications, supportive therapy, tests, labs, and investigational drugs) for all assigned research studies in support of the Epic Beacon build teams. The Protocol Content Administrator, in partnership with a Study Team and an Epic Beacon build team, will ensure that all research-related content in the Epic EHR is accurate and up-to-date for both new and ongoing clinical research trials. The Protocol Content Administrator will also have involvement within the OnCore working environment in areas such as Study Calendar Development and general Research Records, working collaboratively with the OnCore support team, Clinical Trials Support Services, and Clinical Trials Billing.
This individual will bring expertise to the coordination and completion of complex treatment plan builds to support the day-to-day clinical research care operations of the City of Hope. The incumbent will be expected to demonstrate behavioral skills that contribute to a productive work environment and provide excellent customer service to the research fraternity.
Key Responsibilities include:
- Collaborates with Principal Investigators and Study Teams to develop comprehensive protocol-specific content, (including but not limited to detailed delivery instructions for all required pre-medications, supportive therapy, scans, labs and investigational drugs) for assigned research studies
- Coordinates across multiple disciplines to ensure that care instructions are consistent with the scope of practice of each discipline, clear, comprehensive and in keeping with City of Hope standard operating procedure. Supports the efforts of all care providers to deliver quality care.
- Develops and maintains up-to-date tracking and status of all projects, from assignment through completion. Reviews status with management and peers as appropriate. Proactively communicates challenges and escalates appropriately to ensure that assigned projects are completed in a timely manner.
- Actively participates, as a member of the Clinical Research Content Office, on the development of new and efficient workflows to ensure timely delivery of content and facilitation of required validations
- Promotes collaboration and teamwork among all members of the clinical trials office and the healthcare team
- Maintains current knowledge, skills and competencies through involvement in professional continuing education activities
- 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 BS Pharmacy Degree.
- Minimum of 5 years' experience in an academic setting as an RN or Pharmacist, with work directly connected to clinical trials; or equivalent combination of education and clinical research experience.
- Excellent oral/written communication. Strong organizational skills, attention to detail, accuracy, and the ability to work in a team environment.
- 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.
- Proficient in Microsoft Office Word, Excel, Outlook
- Current Pharmacist License OR Current RN License
Preferred education experience and skills:
- Pharm D preferred.
- Epic certification preferably Beacon.
- Oncology Certified Nurse (OCN) preferred.
- Board Certified Oncology Pharmacist (BCOP) preferred.
- Experience in an oncology setting, preferably at least 1 year.
- Epic Beacon Build Experience.
- Previous experience as either a clinical research RN OR clinical research pharmacist preferred.
- Familiarity with Epic and the delivery of care within the Epic EHR environment.
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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