The Clinical Research Assistant provides clinical research support under the direction of the Clinical Research Administration and Clinical Research Regulatory department in the Moores UCSD Cancer Center. Assist with capturing and maintaining data from Moores UCSD Cancer Center clinical studies. Assist in performing standard procedures such as the extraction of data and validation of data prior to inclusion in research databases. Data collection responsibilities include filing, evaluation, assistance with analysis, and reporting for a variety of studies. Maintain database programs and produce reports. Assist with quality control of study participant data, clinical trials protocols, and database entry. Research and resolve data discrepancies between research charts and databases. Assist with preparing files for monitoring visits and internal & external audits, including those by the Cancer Center CTO, Cancer Center DSMB, VA Compliance Office, commercial sponsors, National Cancer Institute, and its cooperative groups. Maintain the regulatory files for the CTO’s clinical trials in accordance with the CTO’s policies and procedures. Assist with the preparation of miscellaneous regulatory documents and distribution to sponsors and/or their representatives of the clinical trials, including FDA form 1572, Protocol Signature Pages, investigator CVs, and clinical laboratory documentation, etc. Assist with UCSD Human Research Protection Program correspondence, and Cancer Center Support Grant supplemental activities. Additional duties include: assisting with clinical trial financial reconciliation, assistance with clinical research funding award submissions and renewals, purchasing supplies and equipment, travel event establishment and reconciliation; and scheduling, attending and recording minutes for clinical research meetings; receiving and triaging clinical trial patient calls, serving as the liaison with UCSD hospital departments and biotechnology/pharmaceutical organizations and other agencies; updating clinical trials website content, and preparing correspondence and documents as needed.
- Theoretical knowledge of biology, microbiology, social sciences, or related field.
- Knowledge of medical and pharmaceutical terminology and concepts, and/or of biological science, sufficient to understand the contents of medical research protocols and research processes. Experience with clinical research.
- Skill, knowledge and ability to use various computer equipment, scanners and software. Knowledge of PC and Mac operating systems in a networked environment. Proficiency in the use of Microsoft Word, Excel, Power Point, email and web browser, and Adobe Acrobat. Ability to learn clinical trials software applications.
- Ability to maintain confidential and sensitive information.
- Knowledge of clinical research protocol and how it is used in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.
- Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as CREDIT, Access, Excel and MS Word.
- Experience performing clinical research duties in a clinical research environment.
- Ability to work as a team member with excellent interpersonal skills, including tact and diplomacy. Ability to successfully interact with staff, faculty and research subjects of varied cultures and educational backgrounds.
- Experience working with FDA policies regulating clinical trials. Experience working with investigational drug authorization criteria.
- Skill in planning, designing and organizing electronic and traditional filing systems and recording procedures to independently follow up on status of pending issues.
- Knowledge and use of grammatically correct English and sentence structure. Ability to compose documents and provide information to research subjects in English in a professional manner.
- Demonstrated knowledge and experience with data entry and database management.
- Experience purchasing medical supplies, and knowledge of laboratory assays, supplies and equipment for purchasing.
- Demonstrated experience monitoring expenses and reconciling purchases.
- Demonstrated experience in contract and grant proposal formats, preparation, submission and administration, as well as Federal, State and private granting agency regulations. Experience with NIH procedures, guidelines and regulations.
- Must be willing to work in a clinical research and patient care environment.
- Must pass a background check and TB skin test prior to employment.
UC San Diego is an Equal Opportunity / Staff Affirmative Action Employer that values a diverse workforce and provides reasonable accommodations to people with disabilities.
UC San Diego Health System is San Diego’s only academic health system and is composed of UC San Diego Medical Center in Hillcrest, and...