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 Vice President, Clinical Research Operations 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. This is an onsite role sitting in Irvine, CA.
Clinical Research Coordinators (CRC) are responsible for maintaining data integrity of multiple assigned research studies. They are responsible for abstracting data, completing case report forms (CRFs) 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. It is their responsibility to create and maintain the research record and maintenance of patient information in the clinical trials management system (CTMS).
The CRC must be well versed in Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, NIH guidelines, and HIPAA regulations. If not already, s/he must become familiar with institutional policy and procedures regarding conducting multiple clinical research trials. Develop and maintain knowledge of institutional protocol submission procedures and requirements. The CRC must be able manage multiple medium to high complexity research projects ensuring quality research conduct, achievement of expected time lines and deliverables, and efficient use of human and practical resources. The CRC must be able to work as a member of the clinical research team with positive and timely written and verbal communication, including sharing information up, down and laterally. This includes communicating protocol deviations or issues with study execution. They are to ensure protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements. The CRC seeks supervision appropriately, prioritizes appropriately, completes work in a timely manner and demonstrates accuracy in all details.Key Responsibilities include: Protocol Compliance
- Ensures all protocol procedures are ordered and completed as specified in the protocol.
- Assembles lab kits and other supplies in preparation to obtain required bio-specimen samples and transports to appropriate laboratories for processing; ships samples externally according to IATA requirements.
- Optimizes the safety of research subjects by ensuring any adverse events (AE) are appropriately reported to the sponsor, study team and institution according to protocol and regulatory requirements.
- Abstracts data from the medical record and completes paper and electronic CRFs including responding to any requests for data clarification.
- Ensures data accuracy with source documentation.
- Ensures documentation processes are followed according to GCP.
- Maintains all necessary patient source documents for assigned studies.
- Obtains data, including images, specimens and medical records, from outside facilities, as needed.
- Responds to all requests for data clarifications of assigned studies.
- Point person to receive AE notification from study team and ensures AE is followed up and/or resolved, as applicable.
- Meets contractual or institutional requirements for timeliness of data entry and query resolution.
- Fulfills sponsor requirements related to reportable information, including: AE, unanticipated problems, other information required by the sponsor protocol.
Other related duties as assigned or requested
- Participates in required teleconferences, study meetings, both on and off-site, as required.
- Attends Disease/Modality Team meetings to ensure any issues are communicated to the team.
- Schedules and participates in interim monitoring visits (IMV) for source data verification (SDV).
- Reviews monitoring reports for assigned studies, determines any discrepancies and resolves outstanding data issues identified by the monitor.
- Adheres to IMV policies of COH.
- Assist the Epic Protocol Content Administrators (PCAs) with questions regarding the protocol procedural requirements, including lab tests, EKG's or imaging.
- Participates in audits and monitor visits for assigned studies, and as requested.
- Identifies and communicates important protocol and data management issues or problems to the PI and supervisor in a timely manner.
- Ensures all patients, for assigned studies, are entered into the CTMS according to COH policies and status is correct.
- Updates patient data in the CTMS to ensure appropriate patient calendars are utilized.
- Assist Clinical Research Billing (CRB) with resolving outstanding data issues or inquiries for financial concerns.
- Participate in the validation of the Epic treatment plans and CTMS calendars for assigned studies.
- Responds to colleagues, faculty, leaders and sponsors in a timely manner.
Basic education, experience, and skills required for consideration:
- Participates in study team meetings.
- Participate in staff meetings.
- Participate in at least 1 CTO working group/committee each year.
- Identifies and participates in professional development activities and opportunities.
- Serve as a resource to other staff regarding assigned protocols.
- Other duties as assigned.
- Job descriptions are not intended and should not be construed to be exhaustive lists of all responsibilities, skills, efforts or working conditions associated with a job.
Preferred Education:Pref. Certification/Licensure:
- Bachelor's Degree preferred or experience in lieu of a degree.
- Two or more years of experience related to the management and conduct of oncology clinical trials in an academic setting. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent forms and protocol development.
- 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
- Microsoft products, Internet and general computer proficiency required.
Working / Environmental Conditions:
- Requires use of computer via keyboard, 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
- Work from home information here.
- 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.
The estimated pay scale represents the typical [salary/hourly] range City of Hope reasonably expects to pay for this position, with offers determined based on several factors which may include, but not be limited to, the candidate's experience, expertise, skills, education, job scope, training, internal equity, geography/market, etc. This pay scale is subject to change from time to time.
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.