| Clinical Research Assistant
39281
The Clinical Research Assistant (CRA) assists with the overall management and implementation of an assigned set of multiple research protocols assuring efficiency and regulatory compliance. The CRA reports to the PI and will work under the direction of Senior CRAs managing clinical trials related to Industry/Children’s Oncology Group (COG)/St. Jude Children’s Research Hospital (SJCRH) sponsored clinical research activities. The CRA is responsible for coordinating the use of cooperative group studies within the Hematology/Oncology (HEM/ONC) Center. The CRA is also responsible for coordinating with the Cancer Center, the GCRC, RMG and/or the IRB the regulatory documents required to open each of the studies.
Duties include:
• Determine patient eligibility for study. Develop and maintain a system to coordinate and submit required data within the time frame determined by the cooperative/pharmaceutical group. Alert investigators, agencies, and appropriate personnel of communications regarding adverse drug reaction reports. Assist in the completion of adverse reaction reports and Medwatches.
• Initiate procedures to obtain surgery, pathology, radiology materials as required by protocol for submission; assist physicians in evaluating the quality of patient care and compliance to study requirements. Act as liaison for physicians, nurses, pharmacists, pathologists, and other allied health care professionals by providing accurate and updated information regarding protocols, clinical research and/or regulatory requirements;
• Maintain accurate records for ordering investigational or nationally sponsored/supplied drugs; prepare and maintain accurate, consistent and complete database for all children, adolescents, and young adults in the study and ensure that data is reported to appropriate governing body within set timeframes according to reporting standards of each group.
• When surgeries are performed, which might be on weekends, holidays or at non-scheduled work hours, the on call CRA is notified and must collect the specimen, prepare it for submission, and submit it in a timely manner. This requires the on-call CRA to wear a pager at least one weekend out of the month to be available to process time sensitive samples. This requires the on-call CRA to wear a pager at least one weekend out of the month.
• Participate in updating protocol manuals with amendments, revisions, and memorandums as appropriate. Maintain filing of closure notices and IRB related correspondence. Review and monitor study coordinator sheets/delinquent data lists. Coordinate the approval and activation of new protocols through the IRB. Develop informed consent forms consistent with IRB, Pharmaceutical and cooperative group requirements. Prepare amendments, revisions, and annual reports for IRB submission. Assist in preparation for site visits and audits.
QUALIFICATIONS:
Bachelor's degree required, preferably in a health related field. At least one year of work experience in a clinical or research laboratory is required. Must have excellent oral and written communication skills; the ability to use the internet and other Computer programs, i.e., Word, Excel, database applications, etc.; exceptional organizational skills and attention to detail required; must be able to multitask and to work independently; must be available at least one weekend out of the month to process time sensitive samples, if necessary. Must be able to interact effectively with a wide range of individuals at all levels in the organization.
Desired:
Knowledge of the principles of clinical research and federal regulations highly desired. Experience with University research policies and procedures would be helpful. Familiarity with IRB guidelines and regulations highly desired. Hematology/Oncology knowledge of laboratory testing and a variety of diagnostic examinations routinely performed in the hospital preferred. Previous experience with therapeutic clinical trials is highly desirable.
Stanford University is an affirmative action, equal opportunity employer. | |
