Clinical Research Coord

City of Hope•Duarte, CA

1d•Onsite

About The Position

Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today. As a successful candidate, you will: The Clinical Research Coordinator (CRC) will be responsible for maintaining data integrity of multiple assigned research studies for 3 Principal Investigators across various Disease Teams. 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 timelines 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. Essential Functions · Ensure all protocol-required procedures are ordered and completed, prepare and transport or ship biospecimens in accordance with IATA requirements, and support participant safety through timely adverse event reporting. · Abstract accurate source data, complete paper and electronic case report forms, maintain patient source documentation, obtain external records and images, and resolve data queries within required timelines. · Maintain assigned studies in an audit-ready state by following Good Clinical Practice, sponsor, institutional, and regulatory documentation and reporting requirements. · Coordinate and participate in study meetings, monitoring visits, audits, and source data verification; review monitoring findings and resolve outstanding protocol and data issues.

Requirements

Minimum Education: Bachelor’s Degree. Experience may substitute for minimum education requirements. (Associate Degree plus minimum of 2 years of experience).
Minimum Experience: 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 form and protocol development.
Well versed in Good Clinical Practices (GCP), Food and Drug Administration (FDA) regulations, NIH guidelines, and HIPAA regulations.

Nice To Haves

Familiarity with institutional policy and procedures regarding conducting multiple clinical research trials.

Responsibilities

Maintaining data integrity of multiple assigned research studies for 3 Principal Investigators across various Disease Teams.
Abstracting data, completing case report forms (CRFs) and answering queries.
Scheduling and meeting with sponsor monitor visits and maintaining data in an audit ready state, meeting the requirements of the contract.
Ensuring compliance to the research protocol and all appropriate regulations.
Creating and maintaining the research record and maintenance of patient information in the clinical trials management system (CTMS).
Developing and maintaining knowledge of institutional protocol submission procedures and requirements.
Managing multiple medium to high complexity research projects ensuring quality research conduct, achievement of expected timelines and deliverables, and efficient use of human and practical resources.
Working as a member of the clinical research team with positive and timely written and verbal communication, including sharing information up, down and laterally.
Communicating protocol deviations or issues with study execution.
Ensuring protocol adherence by understanding, communicating and making sure the study parameters are ordered and carried out per protocol requirements.
Seeking supervision appropriately, prioritizing appropriately, completing work in a timely manner and demonstrating accuracy in all details.
Ensuring all protocol-required procedures are ordered and completed, preparing and transporting or shipping biospecimens in accordance with IATA requirements, and supporting participant safety through timely adverse event reporting.
Abstracting accurate source data, completing paper and electronic case report forms, maintaining patient source documentation, obtaining external records and images, and resolving data queries within required timelines.
Maintaining assigned studies in an audit-ready state by following Good Clinical Practice, sponsor, institutional, and regulatory documentation and reporting requirements.
Coordinating and participating in study meetings, monitoring visits, audits, and source data verification; reviewing monitoring findings and resolving outstanding protocol and data issues.