AVID Technical Resources is seeking an experienced Public Administration Analyst /Clinical Research Associate with Oncology experience to work remotely for our Health Care client in Los Angeles
DUTIES AND RESPONSIBILITIES
1. Act as liaison between study sponsors, regulatory agencies, including the FDA, NCI, Client Drug Information Center and various IRBs.
2. 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.
3. Assist Principal Investigator, Sr. CRA/RN CRA, regulatory team members and team leader in protocol review and study preparation.
4. Assist in preparation of budget grid for review by CRU budget committee and attend budget committee.
5. 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.
6. 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.
7. 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.
8. 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.
9. Assist in obtaining authorizations for protocol specific procedures
10. Assist in scheduling research patients for protocol specific procedures
11. Assist investigators in coordinating and managing patient care activities as outlined in the protocol.
12. Be available to clinic staff, research team, family and patient during research treatments.
13. Ensure study medication is properly provided to patients and they are instructed on medication diaries, and dosing instructions.
14. Conduct drug accountability with patients, which includes review of drug diaries, pill count, and return of empty bottles/vials.
15. Ensure patient has study specific questionnaires to patients, they understand the questions and are completed accurately.
16. Work with study team and Principal Investigator in development of study database for Investigator Initiated trials to track patient demographics, adverse events and study-specific data points.
17. Assists with communications with potential and on-study research patients, tracking, telephone calls and/or letters to patients in long-term study follow up phase, and provides accurate and timely documentation of all communications for the patient’s source medical records and research charts.
- 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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