Clinical Research Coordinator III -GI
Under the direction of the Study Investigators and Disease Team Chair, the supervision of the Clinical Trial Administrators and the leadership of the Clinical Research Nurse Manager, the CRC III coordinates activities to support multiple research studies of all phases and all levels of complexity, including investigator-initiated, IND, First-In-Human, gene therapy or other high profile trials. Functions independently and proficiently with minimal oversight. Serves as the principle administrative liaison for assigned studies and as a technical resource for the department. 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. Mentors and supports new and less experienced staff.
- Works under the direction of the Study Investigators with minimal supervision by the Clinical Trials 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.
- Leads 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
- Mentors new and less experienced staff.
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.
Minimum Education and Skills Required for Consideration:
- Bachelor’s Degree and six or more years as a clinical research coordinator.
- SOCRA or ACRP certification required.
- Excellent oral/written communication and organizational skills.
- Excellent reading comprehension.
- Foster/promote a positive image and professional appearance
- Sensitivity to intercultural relations
- Sensitivity to the maintenance of confidentiality
- Knowledge of Microsoft Products
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 is 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.
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