Only the job description changed.
| Previous Job Description | Current Job Description | ||||
|---|---|---|---|---|---|
| n | 1 | Job Description: | n | 1 | The Clinical Research Coordinator will perform independently or with general direction at the fully |
| > | operational journey level of the series to execute, manage, and coordinate research protocols, as di | ||||
| > | rected by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the da | ||||
| > | ta collection and operations of several concurrent clinical research studies under the guidelines of | ||||
| > | research protocols, UCSF and regulating agency policies. | ||||
| 2 | The Clinical Research Coordinator will perform independently or with general direction at the fully | ||||
| > | operational journey level of the series to execute, manage, and coordinate research protocols, as di | ||||
| > | rected by the Clinical Research Supervisor and/or Principal Investigator (PI); may coordinate the da | ||||
| > | ta collection and operations of several concurrent clinical research studies under the guidelines of | ||||
| > | research protocols, UCSF and regulating agency policies. The incumbent will coordinate a number of | ||||
| > | clinical studies on rheumatic conditions such as systemic lupus erythematosus (SLE), rheumatoid arth | ||||
| > | ritis (RA) or others conditions in rheumatology. Duties include but are not limited to, enrolling pa | ||||
| > | tients in and assisting with execution of 1) industry trials for industry and NIH; 2) enrollment of | ||||
| > | patients in biospecimen banking study from rheumatology clinic; 3) various smaller pilot studies in | ||||
| > | clinic 4) maintaining IRBs; and 5) other research studies as time permits. Responsibilities for all | ||||
| > | studies include: schedule patient visits and procedures; maintain accurate research charts and resea | ||||
| > | rch study binders; perform accurate data collection and data entry; perform patient follow-up visits | ||||
| > | according to specific research study requirements; complete consent procedures and questionnaires w | ||||
| > | ith subjects; participate in research meetings; manage Investigator’s protocols in the Committee on | ||||
| > | Human Research (IRB) online system, as well as renewals and modifications of protocol applications a | ||||
| > | nd the implementation of new studies; participate in the review and writing of protocols to ensure i | ||||
| > | nstitutional review board approval within University compliance; help assure compliance with all rel | ||||
| > | evant regulatory agencies; oversee study data integrity; implement and maintain periodic quality con | ||||
| > | trol procedures; interface with departments to obtain UCSF approval prior to study initiation; maint | ||||
| > | ain all regulatory documents; report study progress to investigators; participate in any internal an | ||||
| > | d external audits or reviews of study protocols; and perform other duties as assigned. Also responsi | ||||
| > | ble for creating research accounts in Apex; linking patients to the research study and keeping their | ||||
| > | research status updated; linking encounters to the study and setting the research billing flag; cre | ||||
| > | ating lab orders and medication orders in Apex; scanning and uploading study consent forms into the | ||||
| > | patient’s medical chart; reviewing lab results, current medications, radiology studies, and provider | ||||
| > | s’ progress notes for data collection into the research study database. The incumbent will also be r | ||||
| > | equired to create and maintain data entry accounts in Redcap and OnCore, the online data entry syste | ||||
| > | ms for research. Perform other duties as needed. There may be other opportunities to assist with oth | ||||
| > | er studies within the Division of Rheumatology. If the incumbent is a certified phlebotomist, perfor | ||||
| > | m phlebotomy as needed. | ||||
| 3 | 2 | ||||
| t | 4 | Qualifications: | t | 3 | The incumbent will coordinate a number of clinical studies on rheumatic conditions such as systemic |
| > | lupus erythematosus (SLE), rheumatoid arthritis (RA) or others conditions in rheumatology. Duties i | ||||
| > | nclude but are not limited to, enrolling patients in and assisting with execution of 1) industry tri | ||||
| > | als for industry and NIH; 2) enrollment of patients in biospecimen banking study from rheumatology c | ||||
| > | linic; 3) various smaller pilot studies in clinic 4) maintaining IRBs; and 5) other research studies | ||||
| > | as time permits. Responsibilities for all studies include: schedule patient visits and procedures; | ||||
| > | maintain accurate research charts and research study binders; perform accurate data collection and d | ||||
| > | ata entry; perform patient follow-up visits according to specific research study requirements; compl | ||||
| > | ete consent procedures and questionnaires with subjects; participate in research meetings; manage In | ||||
| > | vestigator’s protocols in the Committee on Human Research (IRB) online system, as well as renewals a | ||||
| > | nd modifications of protocol applications and the implementation of new studies; participate in the | ||||
| > | review and writing of protocols to ensure institutional review board approval within University comp | ||||
| > | liance; help assure compliance with all relevant regulatory agencies; oversee study data integrity; | ||||
| > | implement and maintain periodic quality control procedures; interface with departments to obtain UCS | ||||
| > | F approval prior to study initiation; maintain all regulatory documents; report study progress to in | ||||
| > | vestigators; participate in any internal and external audits or reviews of study protocols; and perf | ||||
| > | orm other duties as assigned. Also responsible for creating research accounts in Apex; linking patie | ||||
| > | nts to the research study and keeping their research status updated; linking encounters to the study | ||||
| > | and setting the research billing flag; creating lab orders and medication orders in Apex; scanning | ||||
| > | and uploading study consent forms into the patient’s medical chart; reviewing lab results, current m | ||||
| > | edications, radiology studies, and providers’ progress notes for data collection into the research s | ||||
| > | tudy database. The incumbent will also be required to create and maintain data entry accounts in Red | ||||
| > | cap and OnCore, the online data entry systems for research. Perform other duties as needed. There ma | ||||
| > | y be other opportunities to assist with other studies within the Division of Rheumatology. If the in | ||||
| > | cumbent is a certified phlebotomist, perform phlebotomy as needed. | ||||
| 5 | Required Qualifications: - HS graduation and sufficient experience and demonstrated skills to succes | ||||
| > | sfully perform the assigned duties and responsibilities - Attention to detail; strong interpersonal | ||||
| > | skills; excellent, effective verbal and written communication skills to coordinate with subjects, te | ||||
| > | am members, other departments and outside institutions; and the ability to multi-task in a fast-pace | ||||
| > | d environment while working with a diverse subject population - Ability to work well independently, | ||||
| > | complete projects in a timely manner, and prioritize multiple projects to ensure the completion of e | ||||
| > | ssential tasks by deadlines. Preferred Qualifications: - Fluency in the usage of Committee of Human | ||||
| > | Research (CHR) online iRIS IRB system for submission, renewal, and modification of protocols through | ||||
| > | this system. - Understanding of patient population to create rapport and a relationship, while also | ||||
| > | giving insight to what is realistic and appropriate for patient participation. - Experience with el | ||||
| > | ectronic medical records. - Phlebotomy certification - Knowledge of UCSF and departmental policies f | ||||
| > | or dealing with reimbursement, guidelines for research, confidentiality and HIPPA regulations, follo | ||||
| > | wing the UCSF mission statement and purpose for research, and a clear understanding of policies and | ||||
| > | procedures on patient safety and confidentiality (electronic and hard copy medical records, patient | ||||
| > | charts, communication, etc.); knowledge of medical terminology, research policies and guidelines, gu | ||||
| > | idelines for packing/shipping infectious substances, database building/analysis, and data management | ||||
| > | within some of the following: Access, Stata, SASS/ SPSS, and Teleform programming platforms - Exper | ||||
| > | ience applying the following regulations and guidelines: Good Clinical Practice Guidelines Health In | ||||
| > | formation and Accountability Act (HIPAA) The Protection of Human Research Subjects CHR regulations f | ||||
| > | or recruitment and consent of research subjects Effective Cash Handling Procedures Environmental Hea | ||||
| > | lth and Safety Training Fire Safety Training | ||||