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 20 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 Portfolio Supervisor, Senior Director, Clinical Trial Office and the CTO leadership team with input from the Disease Team Chairs and the Study Investigators, the staff of the CTO coordinates activities to support multiple research studies of all phases.
Clinical Research Coordinators (CRC) 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. CRCs 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 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 calendars.Essential Functions:
- Works under the supervision of the Portfolio Supervisor with direction from Study Investigators and the Clinical Trials Manager.
- Works in conjunction with a mentor to develop the skills to assume more responsibility and workload.
- Performs protocol specific duties required per the research protocol, including:
- Abstracts data from the medical record and completes paper and electronic case report forms, including responding to any requests for data clarification, and maintains all necessary source documents.
- Obtains data from outside facilities as needed
- Responds to all requests for data clarifications
- Knowledgeable of sponsor requirements for timeliness of data and response to queries
- Ensures data collection is available per contract obligations at the time of monitoring visits.
- 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.
- Knowledgeable in Good Clinical Practices, Food and Drug Administration Rules and Regulations, NIH guidelines, HIPAA regulations and ICH guidelines in relation to clinical trials. If not already familiar, become familiar with institution Policy and Procedures with particular emphasis in conducting multiple clinical research trials.
- 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 time lines and deliverables, and the efficient use of human and practical resources.
- Troubleshoot problems at all stages of project development and implementation and assist with modifying protocol or project 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.
- Works in conjunction with a mentor to develop necessary skills to complete assignments and tasks.
- Seeks supervision appropriately.
- Plans work in a manner that allows timely completion of all assignments and tasks.
- Demonstrates accuracy in all details.
- Develop and maintain knowledge of institutional protocol submission procedures and requirements.
- Manages low complexity trials after completion of orientation.
- Maintain a processing and tracking system for all protocol related paperwork.
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality.
Performs other related duties as assigned or requested.Position Qualifications: Minimum Education:
- Bachelor's degree. Experience may substitute for minimum education requirements (Associate Degree plus minimum of 2 years of experience).
- At least one year of experience related to the management and conduct of clinical trials in an academic setting, or six months experience as a Project Coordinator or Biospecimen Coordinator in the CTO. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.
- Experience related to the management and conduct of clinical trials
- Certification in Clinical Research, SOCRA or ACRP certification preferred.
- 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
- Computer skills including MS Office products, Internet, and general computer proficiency required.
Working / Environmental Conditions:
- Requires use of computer via keyboard, and operating facsimile machine, calculator, printer, photocopy machine, etc. Requires the use of push-button telephone set. Must be able to master new software by utilizing available resources (other program personnel, reference manual, training classes, etc.)
- Lab Coat or Apron
- If responsible for specimen handling:
- Eye Protection/Goggles
- Face Protection
- Non-Sterile Medical Gloves
- Sterile Medical Gloves
- Academic Research Setting.
- Atmosphere and environment associated with an office setting
- Atmosphere and environment associated with patient care areas
- Tobacco free campus
- Subject to many interruptions
- Occasionally subjected to irregular hours
- Requires judgment that could affect image of City of Hope
- Occasional pressure due to deadline requirements
- Occasional travel required
- Exposed to material of a confidential nature on a regular basis
- Frequent pressure due to multiple calls and inquiries
- Contact with patients/patient families under varied circumstances
- Subject to regularly changing priorities and work assignments
- Subject to handling multiple tasks simultaneously.
- Possible exposure to infectious, radioactive or biohazardous agents
- Subject to varying and unpredictable situations
- Contact with patients/patient families under varied circumstances
- Subject to situations involving grief processes & related issues
- Possibly exposed to the risk of blood borne pathogens
- Ability to maintain a satisfactory work environment by organizing and redistributing files, records, etc., requiring bending, stooping, reaching, manual handling, walking, visually inspecting, extended standing, sitting and repetitive motions. May be required to lift up to 15 pounds. Ability to handle multiple tasks at once.
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.