Senior Clinical Research Coordinator (Regulatory) -SOM: Office of Clinical Research Department- Sacramento Campus
The Office of Clinical Research, along with the other committees listed below, collaborate with the Cancer Center's Clinical Research Advisory Committee (CRAC) in ensuring that appropriate support and oversight is provided to the UC Davis Comprehensive Cancer Center members and sponsors to ensure compliance with all federal, state and local guidelines and requirements.
Job Summary Final Filing Date : 5/14/21 Salary Range : $34.18 to $54.97 Salary Frequency : Hourly Appointment Type : Career Percentage of Time : 100% Shift Hour : Varied Location : Office of Clinical Research City : Sacramento Union Representation : Yes Benefits Eligible : Yes
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
Qualified candidates may be interviewed at any time Responsibilities The Senior Regulatory Coordinator is a health professional possessing advanced communication skills, a willingness to cooperate as a team member and has advanced knowledge of regulatory processes as well as working knowledge of data management activities. The position will support all aspects of regulatory compliance for assigned studies, including but not limited to, maintenance of regulatory documents and submissions to the IRB per local policies and federal regulations.
This position requires certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals and is advanced-level knowledge of federal, local, and institutional regulatory guidelines and provides leadership for a department-wide clinical research program, including mentoring and overseeing junior regulatory coordinators and/or support personnel.
Certification by the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP).
Experience with disease processes as applied to human clinical research.
Minimum 3 years of clinical trial coordination experience.
Advanced experience with federal, local, and institutional regulations and policies (e.g., Food and Drug Administration [FDA], Office for Human Research Protections [OHRP], and Good Clinical Practice [GCP]).
Advanced experience with IRB policies and procedures.
Advanced experience with anatomy and medical terminology.
Demonstrated leadership skills or experience encompassing both training and ongoing coaching.
Experience with Microsoft Office Suite: Word, Excel, Outlook, Access, etc.
Working knowledge of databases and/or Clinical Trial Management System (CTMS).
Analytical skills to evaluate information, changes in practices and procedures, formulate logical and objective conclusions and make recommendations for effective solutions.
Demonstrated oral communication and interpersonal skills to correspond effectively with the public, co-workers, physicians, patients, caregivers, clinic staff and other health care professionals.
Must be able to accurately maintain large volumes of records.
Experience writing and composing reports, using proper grammar, spelling, and punctuation as well as clearly documenting research data onto forms.
Must be able to work independently and/or cooperatively as a team member in a diverse workforce.
Previous experience coordinating oncology trials.
Must be able to work occasional overtime as work demands.
Must be able to travel on occasion.
This position may be subject to a criminal background investigation, drug screen, Live Scan fingerprinting, medical evaluation clearance, and functional capacity assessment.
EEO 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.
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.
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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.