Clinical Research Coordinator II
Under the direction of the Study Investigators and the Disease Team Chair the supervision of the Clinical Trial Administrators and the leadership of the Clinical Research Nurse Manager, the CRC II coordinates activities to support multiple research studies of all phases. Able to successfully manage a workload that includes studies of increased complexity, including selected investigator-initiated and IND trials. Serves as the principle administrative liaison for assigned studies. Develops and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations. Attends clinic as needed to perform activities including, but not limited to: assist the research team with recruitment activities, administer questionnaires and answer any questions about future appointments. Responsible for the compilation, registration and submission of data, as required by the Sponsor.
Key Responsibilities include:
- Works under the direction of the Study Investigators with moderate to minimal supervision by the Clinical Trial Administrator and direction from the Clinical Research Nurse Manager.
- Plays an active role in recruitment of patients to study.
- Performs protocol specific duties required per the research protocol, including:
- Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families.
- Confirms and documents subject eligibility.
- As part of the team, ensures all protocol procedures are ordered and completed as specified in the protocol.
- Randomizes subjects using interactive voice response systems or other systems as applicable.
- Administers standardized tools or questionnaires, such as Quality of Life assessments, if appropriately credentialed.
- Assembles lab kits and other supplies in preparation to obtain required biospecimen samples and transports to appropriate laboratories for processing; ships samples externally according to IATA requirements.
- Optimizes the safety of research subjects by monitoring and reporting any adverse events to the investigators and other members of the study team.
- Participates in required teleconferences, on site meetings and off site investigator meetings, as required.
- Hosts site initiation visits and monitoring or auditing visits.
Regulatory Compliance and Documentation
- Maintains current and accurate documentation in the regulatory binders (paper or electronic) as required by regulations and sponsors.
- Fulfills sponsor requirements related to reportable information, including: adverse events, unanticipated problems, other information required by the sponsor protocol.
- Responsible for the submission of documents to the appropriate IRB and institutional committees on an ongoing basis
- 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.
- Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner.
- Provides staff relief as required to meet the needs of the department.
- Participates in scheduled team/department meetings.
- Participates in and may lead quality improvement projects on an on-going basis including the development of policies and procedures and standard operating procedures to improve day-to-day efficiency
Minimum Education and Skills Required for Consideration:
- Bachelors Degree
- Three or more years as a clinical research coordinator
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 4000 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.
City of Hope strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced. Equal Opportunity / Affirmative Action Employer.
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