AVID Technical Resources is seeking an experienced Public Administration Analyst with Oncology experience for our Health Care client in Los Angeles
DUTIES AND RESPONSIBILITIES
Clinical Trial Duties
- Act as liaison between study sponsors, regulatory agencies, including the FDA, NCI, Drug Information Center and various IRBs.
- Act as liaison between other hospital and clinic departments including but not limited to Surgery, Radiology, Clinical Labs, Pathology, Clinical Research Center, and Sponsored Research.
- Assist Principal Investigator, Sr. CRA/RN CRA, regulatory team members and team leader in protocol review and study preparation.
- Assist in preparation of budget grid for review by CRU budget committee and attend budget committee.
- Participate in protocol order validation meetings and ensure all protocol related worksheets (electronic or otherwise) conform to the protocol and CRFs in order to meet and document all study requirements and assessments.
- 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.
- Assist study team members and Principal Investigators with review of patient records to verify that all study eligibility requirements have been met. Assist with review of patient eligibility documentation prior to enrollment.
- Assists investigators and Sr. CRA/RN CRA in clinic with patient screening, informed consent process, scheduling of procedures and treatments, insurance authorizations, and protocol visits if needed.
Data Management Duties
- Prepare and maintain accurate and complete research charts with copies of all pertinent study records, including signed informed consents, computer generated printouts of research records, appropriate medical source records, physician and nursing notes, radiology, pathology, surgical and laboratory reports, drug accountability, drug ordering, and drug dispensing records, records of patient-specific telephone conversations and material shipping (central laboratory, pathology, or radiology specimens or records) receipts. Records must be maintained and be up to date at all times and available for monitoring and/or auditing.
- Transcribe data obtained from appropriate source documents into study Case Report Forms (CRFs), either electronic or paper-based versions accurately, completely, and in a timely manner according to protocol and contract requirements.
- Work directly with monitors as needed during the monitoring activities to resolve outstanding data issues, obtain missing data, source documents and other study records.
- Notify study staff and investigators of any protocol deviations and/or violations identified in the course of data completion or monitoring activities. Assist study staff and investigators with resolving data discrepancies and developing methods to ensure that study requirements and activities are completed per protocol. Assist study staff with preparing reports to any required regulatory agency regarding protocol issues identified.
- Prepare and submit all SAEs according to protocol and regulatory requirements. Notify study team and investigators of required changes to protocol, informed consents and/or Investigator Brochures (IBs) based on updated safety data, track that the appropriate changes needed to ensure protocol compliance have been implemented.
- Ensure that copies of amended informed consents are available in all appropriate clinics, and that research staff are aware of the need to re-consent patients if the informed consent has been amended. Track that all patients have been re-consented with the amended informed consents if required, and notify study teams and investigators of any outstanding informed consent issues immediately.
- Review drug accountability records and compare drug usage with protocol requirements, patient visits, dose delays and dose modifications. Track drug expiration dates to ensure that no expired drug is used. Notify appropriate study and pharmacy staff of pending drug expiration dates, if required. If required, track that expired study drug has either been returned to the sponsor or was destroyed appropriately per study requirements.
- Collaborate with study fund managers in tracking of study billing and study related expenditures. Assist fund managers with resolution of any billing or study expenditure issues.
- Check lab values in EMR and provide to MD for review in order to clear patients for treatment. Review any potential dose reductions or protocol requirements associated with the lab values with MD.
- Provide in-services for clinic staff with the CRC on new studies.
- Demonstrated working knowledge of current medical terminology specific to oncology, to accurately read entries in patient charts and record accurately 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 and studies
- Demonstrated knowledge of “good clinical practices” for clinical research as defined by the FDA
- Demonstrated organizational skills to efficiently and effectively provide data management/monitoring support for multiple clinical trials and projects, providing accurate information in a timely manner
- Demonstrated understanding of confidential information, how it is defined, and demonstrated skill in maintaining confidential status of such information
- Demonstrated ability to prioritize workload to meet demands of PI’s, Sponsor and FDA
- Demonstrated knowledge of all components the research process as it pertains to clinical trials and studies, i.e., IRB procedures and processes, data management, patient care management, etc
- Demonstrated interpersonal skills to work with patients, their families/ guardians, physicians, administrators, work colleagues, representatives from sponsors and other to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner
- Ability to understand that work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner. Notify direct supervisor of any conflicts in demand on time or priorities
- Computer skills using PC platform computers with proficiency in Excel, Word, FileMaker pro to enter data and generate correspondence accurately
- Demonstrated English writing skills to generate original correspondence, including reports, using correct grammar, syntax and punctuation
- Demonstrated English verbal skills to obtain and convey accurate information, explaining research protocol to patients and other staff
- Ability to work at more than one site, travel to participating clinics and attend off-site staff meetings, conferences and investigators meetings
- Ability to complete tasks with a high degree of accuracy
- Experienced in performing assessments and interventions under the direction of the principal investigator with acutely ill oncology patients using strong clinical judgment and up to date oncology knowledge
- Ability to work flexible hours to accommodates research procedure and deadlines.
About AVID Technical Resources:
AVID (Applications, Voice, Internet, Data) Technical Resources is a contract and permanent IT recruiting company. Headquartered in Boston with 9 offices around the US, AVID specializes in placing information technology professionals with either an Infrastructure Support or Applications Development background.
Since our inception in 2003, AVID has grown to be among the leading IT recruiting firms in the area. This explosive growth has led to a number of awards and recognition. Inc. Magazine listed AVID three times on their exclusive Inc. 500/5000 Fastest Growing Privately-Held Companies in the US. AVID was named one of the Leading IT Staffing Agencies in the Northeast by Forbes Magazine and the Boston Business Journal ranked AVID Technical Resources the 7th Fastest Growing Privately-held Company in Massachusetts. AVID Technical Resources has not only been recognized by local and national business and staffing organizations, but also by its most important critics: our clients and candidates. Check out our reviews on Glassdoor, Indeed, and Google here.
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