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
The Clinical Trial Office (CTO) assists COH investigators with the management of research studies involving human subjects. Under the direction of the Senior Director, Clinical Trial Office and the CTO leadership team with input from the Disease/Modality Team Chairs and the Study Investigators, the staff of the CTO coordinates activities to support multiple research studies of all phases.
Principal Clinical Research Coordinators (PCRC) are responsible for serving as leads within their respective disease teams mentoring new staff, providing task level guidance to CRCs and ACRCs, and serving as subject matter experts in key CTO processes.
In addition to the lead activities, PRCs are responsible for maintaining data integrity of assigned research studies. They are responsible for abstracting data, completing case report forms and answering queries. They schedule and meet with sponsor monitor visits and maintain data in an audit ready state, meeting the requirements of the contract. PCRCs are also responsible for ensuring compliance to the research protocol and all appropriate regulations. They attend clinic, when required, and assist the Clinical Research Nurses (CRNs) with study management and ensure patient satisfaction and understanding with protocol requirements. They assist with recruitment activities, administer questionnaires, answer questions about future appointments, register and randomize patients to study. It is their responsibility to create and maintain the research record, help with insurance authorization, and maintenance of the financial and study calendars.Key Responsibilities include:
Basic education, experience and skills required for consideration:
- Works under the supervision of the Senior Director, CTO Study Management Operations and/or CTO senior leadership with direction from Study Investigators.
- Ensures data management duties are performed and complete for assigned research protocols, including but not limited to:
- Complete and timely data entry from the medical record into study case report forms (CRFs),
- Timely response to any requests for data clarification or query resolution;
- Maintenance of all necessary source documents;
- Receipt and entry of data from outside facilities, as needed;
- Knowledgeable of sponsor requirements for timeliness of data and response to queries; and
- Ensures data collection is available per contract obligations at the time of monitoring visits.
- Serves as liaison, as needed, to sponsor for assigned studies after activation.
- Reports and oversees follow-up and resolution of Adverse Events (AEs):
- Point person to receive AE notification from study team;
- Ensures SAEs, AEs, Deviations and Ups are reported to regulatory agencies and institution appropriately.
- Fulfills sponsor requirements related to reportable information, including: adverse events, unanticipated problems, other information required by the sponsor protocol.
- Participates in audits and monitor visits for assigned studies, and as requested.
- Provides patient facing support and back-up for CRN collaborator. Includes, assisting with consenting, specimen collection requisitions, and in-person data collection, including IP reconciliation.
- Identifies and communicates important protocol and data management issues or problems to the supervisor and/or leadership in a timely manner.
- Responsible for ensuring patient scheduling for protocol and study related procedures and communicating with the patient.
- Oversees completion of insurance authorization for study related procedures that are considered standard of care;
- Ensures Epic treatment plans are accurate and correct according to the research protocol, including participating in validation meetings.
- Ensures all protocol orders are submitted and signed in EMR 48 hours prior to patient visit, unless kit assignments or IVRS precludes 48 hours, must ensure pharmacy and BCCR are aware of the timelines.
- Communicate with appropriate individual(s) regarding upcoming deadlines, data locks, monitoring visits and audits.
- Serve in a leadership and mentor capacity to colleagues on their assigned teams, including but not limited to CRNs, CRCs, ACRCs, and regulatory or administrative staff.
- Assist in training new staff in the CTO as assigned by leadership.
- Monitor and coordinate multiple research projects in order to assess the need for and to implement strategies to ensure the conduct of quality research, the achievement of expected timelines and deliverables, and the efficient use of human and practical resources.
- Review, in advance, all assigned studies for feasibility and budgeting needs.
- Troubleshoot problems at all stages of project implementation and assist with operationalizing the protocol or procedures to address challenges.
- Ensure protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements.
- Work as a member of the clinical research team with positive and timely written and verbal communication, including sharing information up, down and laterally.
- Shows initiative to identify and implement ways to improve job and surroundings
- Seeks supervision appropriately.
- Plans work in a manner that allows timely completion of all assignments and tasks.
- Develop and maintain knowledge of institutional protocol submission procedures and requirements.
- Demonstrates accuracy in all details.
- Manages trials of all level of complexity.
- Bachelor's degree.
- Minimum of five years of experience related to the management and conduct of clinical trials in an academic setting.
- Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.
Preferred education experience and skills:
- Current certification in Clinical Research, SOCRA or ACRP Certification, or obtained within three (3) months of hire.
- Advanced degree in healthcare or medical field.
- At least 2 years of experience in oncology related research.
- Medical Terminology.
- Excellent skills in time management, prioritization, and multi-tasking required. Strong organizational skills Ability to practice independently, strong verbal and written communication skills, organizational and critical judgment skills, and be able to interact effectively with co-workers and customers. Strong attention to detail. Ability to focus on task is essential.
- Be clearly understood by verbal communication in face-to-face encounters and by telephone. Must be able to engage in a variety of telephone and face-to-face meetings related to pending and active projects on a daily basis.
- Strong command of the English language, including spelling, writing, and verbalizing and ability to communicate well verbally and in writing. Must be able to read, interpret, and process large quantities of printed information. Foster/promote a positive image and professional appearance. Sensitivity to intercultural relations. Sensitivity to the maintenance of confidentiality.
- Access data in computer data bases
- Compile data
- Proofread documents
- Research information
- Troubleshoot problems
- Use computer packages
- Use word-processing software
- To protect the health of patients and staff and to comply with new State of California mandates, City of Hope staff are required to show proof of full vaccination by September 30, 2021. Compliance is a condition of employment.
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.