USC CERPP (Center for Enrollment Research, Policy and Practice)
Research Coordinator I
USC CERPP (Center for Enrollment Research, Policy and Practice), Los Angeles, California, United States, 90079
Overview
Be among the first 25 applicants. This position requires a strong medical background and an interest in clinical research. The Research Coordinator I works independently and with physicians, patients, data managers, and other hospital personnel. The Coordinator is accountable to the Medical Director and Associate Director of CISO and to the Principal Investigators with whom they work. The Coordinator follows the policies and procedures of the hospital. Responsibilities
Research
Review in-house protocols prior to CIC approval, focusing on necessity and feasibility of required study tests, patient compliance, dose modification, and drug toxicities. May provide information regarding time or effort to facilitate budget setup. Ensure that the study is conducted as written so that scientific questions are answered. Conduct ongoing assessment of protocol deviations and violations. Participate in NCI, FDA, and pharmaceutical audits; adhere to their regulations, especially regarding reporting of Serious Adverse Events. Enter SAE into iStar for reporting to the IRB and notify Data Managers promptly of SAEs. Interact with monitors/auditors from sponsoring pharmaceutical companies. Protocol Administration
Determine patient eligibility Schedule necessary tests Ensure that written informed consent is obtained using the correct version of the stamped Informed Consent; answer patient questions regarding study and toxicities Calculate correct drug doses based on Body Surface Area (BSA); adjust doses as needed for toxicity with possible recalculation
Protocol Compliance
Ensure correct dates for return clinic appointments or hospital admissions Schedule or ensure required tests and procedures for follow-up are completed Coordinate with outside facilities to ensure protocol adherence and obtain treatment records and outside laboratory results Record study toxicities accurately and report SAEs within required timelines (FDA guidelines) Assist with data management (CRF completion) on certain protocols and patients as requested Follow CISO SOPs
Patient Care Related
Physician/Investigator Interaction
Discuss patient eligibility questions and concerns Serve as liaison between patient and physician for medical issues Notify physician of Serious Adverse Events and keep physician updated on patient problems Discuss toxicities, protocol deviations, or violations that may require a protocol revision Ensure tumor measurements are obtained and calculate responses; ensure physician signs the Tumor Flow Sheet Generate data for ongoing evaluation of the study when requested
Patient Interaction
Screen for potential protocol patients on request Coordinate pre-study evaluations and determine final eligibility for trial Follow up with patients for questions regarding the study and toxicities Assess psychosocial needs to ensure patient compliance Conduct thorough pre-study assessment for baseline toxicity information Educate patients about possible toxicities; instruct patients to call with questions; act as initial contact for problems and triage calls appropriately with the physician See patient at each visit for ongoing toxicity assessment; document and report adverse reactions; ensure treating physician countersigns the Toxicity Assessment Form; modify drug dose if necessary Performs other related duties as assigned
Qualifications
Preferred Education:
Bachelor’s Degree; combined experience/education acceptable Preferred Experience:
2 years Minimum Education/Experience:
Bachelor’s degree; combined experience/education acceptable; 1 year minimum experience; administrative or research experience; working knowledge of MS Office; strong communication and writing skills; ability to multi-task and prioritize; ability to work as part of a team and independently Attachments and other requirements may include Cover Letter and Résumé; optional: Letters of reference.
#J-18808-Ljbffr
Be among the first 25 applicants. This position requires a strong medical background and an interest in clinical research. The Research Coordinator I works independently and with physicians, patients, data managers, and other hospital personnel. The Coordinator is accountable to the Medical Director and Associate Director of CISO and to the Principal Investigators with whom they work. The Coordinator follows the policies and procedures of the hospital. Responsibilities
Research
Review in-house protocols prior to CIC approval, focusing on necessity and feasibility of required study tests, patient compliance, dose modification, and drug toxicities. May provide information regarding time or effort to facilitate budget setup. Ensure that the study is conducted as written so that scientific questions are answered. Conduct ongoing assessment of protocol deviations and violations. Participate in NCI, FDA, and pharmaceutical audits; adhere to their regulations, especially regarding reporting of Serious Adverse Events. Enter SAE into iStar for reporting to the IRB and notify Data Managers promptly of SAEs. Interact with monitors/auditors from sponsoring pharmaceutical companies. Protocol Administration
Determine patient eligibility Schedule necessary tests Ensure that written informed consent is obtained using the correct version of the stamped Informed Consent; answer patient questions regarding study and toxicities Calculate correct drug doses based on Body Surface Area (BSA); adjust doses as needed for toxicity with possible recalculation
Protocol Compliance
Ensure correct dates for return clinic appointments or hospital admissions Schedule or ensure required tests and procedures for follow-up are completed Coordinate with outside facilities to ensure protocol adherence and obtain treatment records and outside laboratory results Record study toxicities accurately and report SAEs within required timelines (FDA guidelines) Assist with data management (CRF completion) on certain protocols and patients as requested Follow CISO SOPs
Patient Care Related
Physician/Investigator Interaction
Discuss patient eligibility questions and concerns Serve as liaison between patient and physician for medical issues Notify physician of Serious Adverse Events and keep physician updated on patient problems Discuss toxicities, protocol deviations, or violations that may require a protocol revision Ensure tumor measurements are obtained and calculate responses; ensure physician signs the Tumor Flow Sheet Generate data for ongoing evaluation of the study when requested
Patient Interaction
Screen for potential protocol patients on request Coordinate pre-study evaluations and determine final eligibility for trial Follow up with patients for questions regarding the study and toxicities Assess psychosocial needs to ensure patient compliance Conduct thorough pre-study assessment for baseline toxicity information Educate patients about possible toxicities; instruct patients to call with questions; act as initial contact for problems and triage calls appropriately with the physician See patient at each visit for ongoing toxicity assessment; document and report adverse reactions; ensure treating physician countersigns the Toxicity Assessment Form; modify drug dose if necessary Performs other related duties as assigned
Qualifications
Preferred Education:
Bachelor’s Degree; combined experience/education acceptable Preferred Experience:
2 years Minimum Education/Experience:
Bachelor’s degree; combined experience/education acceptable; 1 year minimum experience; administrative or research experience; working knowledge of MS Office; strong communication and writing skills; ability to multi-task and prioritize; ability to work as part of a team and independently Attachments and other requirements may include Cover Letter and Résumé; optional: Letters of reference.
#J-18808-Ljbffr