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Clinical Trials Data Coordinator - Remote
Company | City of Hope |
Address | California, United States |
Employment type | FULL_TIME |
Salary | |
Category | Non-profit Organizations,Research Services,Hospitals and Health Care |
Expires | 2023-08-03 |
Posted at | 10 months ago |
About City Of Hope
- Ensures all protocol procedures are ordered and completed as specified in the protocol.
- Administration
- Serve as a resource to other staff regarding assigned protocols.
- Ensures data accuracy with source documentation.
- Other related duties as assigned or requested
- Identifies and participates in professional development activities and opportunities.
- Meets contractual or institutional requirements for timeliness of data entry and query resolution.
- Participates in audits and monitor visits for assigned studies, as requested.
- Ensures documentation processes are followed according to GCP.
- Participate in staff meetings.
- Reviews monitoring reports for assigned studies, determines any discrepancies and resolves outstanding data issues identified by the monitor.
- Attends Disease/Modality Team meetings to ensure any issues are communicated to the team.
- Responds to all requests for data clarifications of 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.
- Participates in study team meetings.
- Fulfills sponsor requirements related to reportable information, including: AE, unanticipated problems, other information required by the sponsor protocol.
- Obtains data, including images, specimens and medical records, from outside facilities, as needed.
- Identifies and communicates important protocol and data management issues or problems to the PI and supervisor in a timely manner.
- Maintains all necessary patient source documents for assigned studies.
- Abstracts data from the medical record and completes paper and electronic CRFs including responding to any requests for data clarification.
- 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.
- Schedules and participates in interim monitoring visits (IMV) for source data verification (SDV).
- Participates in required teleconferences, study meetings, both on and off-site, as required.
- Data Management & Protocol Compliance
- At least two years of experience related to the conduct of oncology clinical trials.
- Bachelor’s Degree, relevant experience may substitute for degree.
- Working knowledge of clinical trials, Federal, State, and Local Regulations, and IRB requirements.
- There are multiple positions 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.
- At least two years of experience related to the conduct of oncology clinical trials.
- Bachelor’s Degree, relevant experience may substitute for degree.
- Working knowledge of clinical trials, Federal, State, and Local Regulations, and IRB requirements.
- There are multiple positions available.
- 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.
- As a condition of employment, City of Hope requires staff to comply with all state and federal vaccination mandates.
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