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Clinical Research Coordinator Jobs
Company | City of Hope |
Address | Irvine, CA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Non-profit Organizations,Research Services,Hospitals and Health Care |
Expires | 2023-07-31 |
Posted at | 9 months ago |
About City Of Hope
- Point person to receive AE notification from study team and ensures AE is followed up and/or resolved, as applicable.
- Ensures data accuracy with source documentation.
- Participate in staff meetings.
- Protocol Compliance
- Responds to colleagues, faculty, leaders and sponsors in a timely manner.
- 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.
- Participate in at least 1 CTO working group/committee each year.
- Identifies and participates in professional development activities and opportunities.
- Meets contractual or institutional requirements for timeliness of data entry and query resolution.
- Updates patient data in the CTMS to ensure appropriate patient calendars are utilized.
- 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.
- Abstracts data from the medical record and completes paper and electronic CRFs including responding to any requests for data clarification.
- Reviews monitoring reports for assigned studies, determines any discrepancies and resolves outstanding data issues identified by the monitor.
- Adheres to IMV policies of COH.
- Fulfills sponsor requirements related to reportable information, including: AE, unanticipated problems, other information required by the sponsor protocol.
- Attends Disease/Modality Team meetings to ensure any issues are communicated to the team.
- Obtains data, including images, specimens and medical records, from outside facilities, as needed.
- Assist the Epic Protocol Content Administrators (PCAs) with questions regarding the protocol procedural requirements, including lab tests, EKG’s or imaging.
- Assist Clinical Research Billing (CRB) with resolving outstanding data issues or inquiries for financial concerns.
- Schedules and participates in interim monitoring visits (IMV) for source data verification (SDV).
- Data Management
- Participates in audits and monitor visits for assigned studies, and as requested.
- Participates in required teleconferences, study meetings, both on and off-site, as required.
- Serve as a resource to other staff regarding assigned protocols.
- Ensures all protocol procedures are ordered and completed as specified in the protocol.
- Other related duties as assigned or requested
- Participates in study team meetings.
- Participate in the validation of the Epic treatment plans and CTMS calendars for assigned studies.
- 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.
- 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.
- Administration
- Ensures documentation processes are followed according to GCP.
- Responds to all requests for data clarifications of assigned studies.
- Maintains all necessary patient source documents for assigned studies.
- Bachelor’s Degree. Experience may substitute for minimum education requirements (Associate Degree plus minimum of 2 years of 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.
- SOCRA or ACRP certification preferred
- Multiple On-Site Positions are Available
- As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.
- 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.
- Two or more years of experience related to the management and conduct of oncology clinical trials in an academic setting.
- Bachelor’s Degree. Experience may substitute for minimum education requirements (Associate Degree plus minimum of 2 years of experience).
- Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development.
- SOCRA or ACRP certification preferred
- As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.
- 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.
- Multiple On-Site Positions are Available
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