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Clinical Research Data QA & Regulatory Specialist or Sr. Clinical Research Data QA & Regulatory Specialist - SOM: Internal Medicine Infectious Diseases - Sacramento Campus
University of California Davis Health System
Clinical Research Data QA & Regulatory Specialist or Sr. Clinical Research Data QA & Regulatory Specialist - SOM: Internal Medicine Infectious Diseases - Sacramento Campus
University of California Davis Health System
 Clinical Research Data QA & Regulatory Specialist or Sr. Clinical Research Data QA & Regulatory Specialist - SOM: Internal Medicine Infectious Diseases - Sacramento Campus Department Description School of Medicine Internal Medicine Infectious Diseases has two positions available for two levels of Clinical Research Coordinators (CRC). Based on qualifications, selected candidate may be hired at either a Clinical Research Coordinator (CRC) or Sr. Clinical Research Coordinator (Sr. CRC). Job Summary *This position may be eligible for a hiring bonus.* We offer exceptional employment benefits including medical, dental, and vision plans, generous paid vacations and holidays, excellent retirement savings and investment plans, continuing education, and reduced fee and scholarship programs. THIS IS NOT AN H1- B OPPORTUNITY Responsibilities Sr. CRC positions at this level independently coordinate and are accountable for the data and regulatory aspects of multiple clinical studies, requiring advanced- level knowledge and skills. They provide regulatory oversight and leadership to lower-level clinical research coordinators and/or other support personnel. This position will have high level knowledge of clinical research data and regulatory activities. They will be adept at problem-solving with respect to data integrity and source documentation. They may manage and help develop strategies, policies, processes and resources, and function with a high level of autonomy in partnership with the supervisor and PIs. CRC responsibilities may include, but are not limited to: study start-up, budget negotiation, subject recruitment, screening, enrollment, scheduling, data collection, participant tracking, invoicing, IRB submissions, modifications, and amendments, annual renewals, obtaining financial disclosure information from the investigators, preparation for audits and monitor visits, study closeouts, and assisting with administrative requirements, and collection and maintenance of study regulatory documents. Required Qualifications Applicants are encouraged to upload license and certification if required of the position. Sr. CRC Certification by the Society of Clinical Research Associates (SOCRA) or the Association of Clinical Research Professionals (ACRP) At least two years experience in managing data/quality assurance and regulatory submission related to clinical trials or observational studies. Experience in independently organizing tasks and setting priorities for work assignments to achieve timely progress on multiple tasks simultaneously, to meet deadlines and maintain a high level of productivity. Experience working with computer systems and databases, including Windows, Microsoft Office Suite, electronic medical records, and electronic data capture systems for clinical research. Advanced knowledge and understanding of FDA regulations, ICH guidelines, Good Clinical Practice (GCP), federal and Institutional Review Board guidelines. Excellent skills to exercise discretion, initiative and resourcefulness and make independent judgments based on sound analysis. Must understand and follow federal, state, and university regulations for conducting research on human subjects CRC: Experience in independently organizing tasks and set priorities for work assignments to achieve timely progress on multiple tasks simultaneously, to meet deadlines and maintain a high level of productivity. Experience working with computer systems and databases, including Windows, Microsoft Office Suite, electronic medical records, and electronic data capture systems for clinical research. Experience in clinical research or other positions with transferrable skills. Knowledge and understanding of FDA regulations, ICH guidelines, Good Clinical Practice (GCP), federal and Institutional Review Board guidelines. Excellent skills to exercise discretion, initiative and resourcefulness and make independent judgments based on sound analysis. Leadership skills encompassing both training and ongoing mentoring of jr. research team members. Preferred Qualifications Sr. CRC Bachelor's degree Advanced-level knowledge and understanding of infectious diseases medicine and disease processes as applied to clinical research. CRC: Experience to independently comprehend and implement complex clinical research protocols, with careful attention and strict adherence to detail. Experience coordinating a broad range of activities from inception to implementation within the confines of strict study protocols, University (or similar) and policies and procedures. Prior experience as a Research Coordinator. Bachelor' s Degree Special Requirements Required to work occasional overtime as work demands. Required to travel on occasion for training and educational purposes. This position may be subject to a criminal background investigation, drug screen, Live Scan fingerprinting, medical evaluation clearance, and functional capacity assessment. The University of California has implemented a SARS-CoV-2 (COVID-19) Vaccination Program SARS-CoV-2 Vaccination Policy (ucop.edu) covering all employees. To be compliant with the policy, employees must submit proof of vaccination or a University-approved exception or deferral. Diversity, Equity, Inclusion and Belonging At UC Davis, we're solving life's most urgent challenges to bring a fuller, healthier, and more resilient world within reach. We grow from every challenge we take on and we don't just maintain - we improve. We recognize that creating an inclusive and intellectually vibrant organization means understanding and valuing both our individual differences and our common ground. The most comprehensive solutions come from the most diverse minds and you belong here. As you consider joining UC Davis, please explore our Principles of Community, our Clinical Strategic Plan and strategic vision for research and education, and our latest efforts to outgrow the expected. The University of California is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy. Final Filing Date 10/02/2023, Interviews may be held at any time. Salary Range Sr. CRC $36.44 - $58.60 CRC $30.03 - $48.29 Salary Frequency Hourly Appointment Type Career Number of Positions 2 Percentage of Time 100% Shift Hour 08 Hours Location Patient Support Services Bldg. City Sacramento Union Representation Yes Benefits Eligible Yes To apply, visit https://careerspub.universityofcalifornia.edu/psp/ucdmed/EMPLOYEE/HRMS/c/HRS_HRAM.HRS_APP_SCHJOB.GBL?Page=HRS_APP_JBPST&Action=U&FOCUS=Applicant&SiteId=5&JobOpeningId=44644&PostingSeq=1 The University of California is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy. Copyright 2022 Jobelephant.com Inc. All rights reserved. Posted by the FREE value-added recruitment advertising agency jeid-131e2ba7388619439a20dbdbec6e3a09
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Internal Number: 4604673
About University of California Davis Health System
UC Davis is the home of the Aggies — go-getters, change makers and problem solvers who make their mark at one of the top public universities in the United States. Since we first opened in 1908, we’ve been known for standout academics, sustainability and Aggie Pride as well as valuing the Northern California lifestyle. These themes are woven into our 100-plus-year history and our reputation for solving problems related to food, health, the environment and society.Our 5,300-acre campus is in the city of Davis, a vibrant college town of about 68,000 located in Yolo County. The state capital is 20 minutes away, and world-class destinations such as the San Francisco Bay Area, Lake Tahoe and the Napa Valley are within a two-hour drive.
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