Vacancy expired!
- Prepare, process, and ship biological specimens, including liquid and tumor specimens.
- Assist Principal Investigators and research teams with the collection of patient records and source documents.
- Request outside records, tumor slides and blocks, images or any other necessary protocol require documentation.
- Prepare and track study laboratory or pathology specimens stored or shipped to central laboratories or facilities according to protocol requirements, and to ensure that they have been processed and received in an appropriate manner.
- Resolve any missing data and/or shipping issues regarding specimens with central laboratories or facilities and ensure that the specimens have been returned to the originating site or facility if required.
- Attend study initiation meetings and participate in study initiation and staff training events (teleconferences and/or meetings). Assist study team with training and orientation of clinic treatment staff regarding protocol requirements.
- Enter source data into the case report forms (CRF) in a timely and accurate manner and according SOP and CRF Completion Guidelines.
- Review and resolve data queries in a timely manner, according to the protocol/contract or SOP.
- Assist with communications (telephone calls and/or letters) with research participants active on study or in long-term follow up phase and provide accurate and timely documentation of all communications for the patient’s source medical records and research charts.
- Prepare, review and maintain accurate, timely and complete research charts with original source documents and copies of all pertinent study records, making any necessary corrections to errors per SOP.
- Enter patient data entry into the Clinical Research Management System (CRMS), in order to document all patient enrollment, screen failures, protocol and unscheduled visits, protocol deviations, and Serious Adverse Events.
- Review all monitoring and auditing reports from Sponsors or granting agencies for all assigned studies, for a completeness, accuracy, discrepancy or protocol deviations.
- Maintain confidential filing system for research files, study participant files, and other correspondence. Assist with labeling, faxing, photocopying, filing, as needed.
- Handle correspondence and communications as appropriate; compose Memos to Files (MTF), letters or memos of response, telephone triage, when necessary.
- Assist in obtaining signatures from physicians, clinic, and research staff.
- Participate in weekly disease specific meetings and update investigators and staff on patients and study specifics
- Assist in quality control and quality assurance activities, including participation in internal QA audits and Sponsor/FDA audits as required.
- Provide cross coverage for vacation and sick time for team members, as required.
- Work flexible hours and/or overtime to meet study deadlines and requirements, when required.
- Attend all CRU, research, and staff meetings, as required.
- Ensure all training (e.g., CITI, HIPAA, GCP, IATA, INFORM, Rave, etc.) is up-to-date and current.
- Travel to different research locations, as necessitated by the protocol or regulations.
- Demonstrated working knowledge of current medical terminology specific to oncology, to accurately read entries in patient charts, and record accurate and timely information into study records and other appropriate research data forms.
- Clinical research experience, with in-depth knowledge of clinical oncology as it pertains to clinical trials.
- Working knowledge of “Good Clinical Practices,” as defined by the FDA.
- Demonstrated organizational skills to provide data management/monitoring support efficiently and effectively for multiple clinical trials and projects, providing accurate information in a timely manner.
- Demonstrated understanding of confidential information (Protected Health Information).
- Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.
- Demonstrated English writing skills to generate original correspondence, including reports, using correct grammar, syntax, and punctuation.
- Demonstrated experience working with Electronic Medical Record (EMR) systems such as Epic, Cerner, etc.
- Ability to work in a fast-paced environment and to shift priorities to meet deadlines.
- Skills in performing duties with frequent interruptions and/or distractions.
- Willingness to travel between client’s Westwood and Santa Monica Clinic.
- Ability to work with a high level of accuracy especially when preparing lab specimens for shipment and/or delivery to clinical research laboratories.
- Ability to lift/push/pull up equipment up to approximately 30 lbs.
Vacancy expired!