Clinical Research Coordinator I
Requisition ID: 10314
Job Title: Clinical Research Coordinator - I
Position Summary and Key Responsibilities:
Under the direction of the Study Investigators and Disease Team Chair, mentorship of experienced clinical research coordinator staff, supervision of the Clinical Trials Administrators and the leadership of the Clinical Research Nurse Manager, the CRC I coordinates activities to support research studies. Able to manage low complexity trials after completion of orientation. Assignments are gradually adjusted to add increased responsibility based on demonstrated competency. Mentored by an experienced clinical research coordinator II or III, serves as the principle administrative liaison for assigned studies. Follows 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.
- Works under the supervision of the Clinical Trials Administrator, Investigators, Disease Team Chair and the direction of the Clinical Research Nurse Manager.
- Works in conjunction with a clinical research coordinator mentor and the oversight of a Clinical Trial Administrator to gradually assume more responsibility and workload
- Assists in the recruitment of patients to study by helping to identify potential eligible patients who are scheduled to be seen in the clinic and communicating the information to the Study Team .
- Performs protocol specific duties required per the research protocol, including but not limited to:
- 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 International Air Transport Association (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 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
Follows established City of Hope and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, includingadherence to theworkplaceCode 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 less than three or more years as a clinical research coordinator.
- Knowledge of medical terminology.
- Exposure to clinical trials or related health field is preferred.
- 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.
- Ability to use Microsoft products, access data in computer data bases, compile data, and research information.
- Proofread documents.
- Troubleshoot problems.
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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