Senior Regulatory Clinical Research Coordinator- SOM: Cancer Center Department - Sacramento Campus
The UC Davis Comprehensive Cancer Center (UCDCCC) is a matrix organization under the aegis of UC Davis Health and University of California, Davis. Designated by the National Cancer Institute as a Comprehensive Cancer Center, the Center is a clinical and research enterprise consisting of over 300 faculty members from the Davis, Sacramento and Lawrence Livermore National Laboratory campuses. As part of the Cancer Center, the UC Davis Cancer Care Network (CCN) is a unique partnership with centers from Northern and Central California that work together to offer patients first-rate, leading-edge oncology care close to home. The Cancer Care Network services include but are not limited to oncology physician support/education, education/training for oncology nursing, pharmacy coding/billing, community-focused virtual tumor boards, and cancer clinical trials with IRB/regulatory support.
Job Summary Final Filing Date : 2/5/21 Salary Range : $34.18 to $54.97 Salary Frequency : Hourly Appointment Type : Career Percentage of Time : 100% Shift Hour : Day Location : UC Davis Cancer Care Network, 4501 X Street 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
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 a working knowledge of data management activities. This position requires certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals. Advanced-level knowledge of federal, local, and institutional regulatory guidelines is also required. This position will work in conjunction with the Office of Clinical Research (OCR) to provide leadership for clinical trials regulatory processes for the Cancer Care Network (CCN) affiliate sites including regulatory oversight, interacting with clinical research coordinators, CCN leadership and other members of the research team within the CCN. Travel and occasional overtime will be required.
Certification by the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP).
Knowledge and understanding of disease processes as applied to human clinical research.
Minimum 3 years of clinical trial coordination experience
Advanced knowledge of 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]) is essential.
Advanced level knowledge of IRB policies and procedures.
Advanced level knowledge of anatomy and medical terminology.
Demonstrated leadership skills or experience encompassing both training and ongoing coaching
Experienced 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.
Demonstrate oral communication and interpersonal skills to correspond effectively with the public, co-workers, physicians, patients, caregivers, clinic staff and other health care professionals.
Display organizational skills and attention to detail so that large volumes of records can be accurately maintained to accomplish a task or goal in a timely manner.
Display writing skills including ability to compose reports and correspondence while utilizing correct grammar, spelling and punctuation as well as clearly documenting research data onto forms.
Ability to work independently and/or cooperatively as a team member in a diverse workforce.
Ability to work occasional overtime as work demands.
All health practitioners have mandatory reporting responsibilities when an adult (or a minor who meets special circumstances as described in UCDMC Hospital P&P 1408) presents at UCDMC as an outpatient or inpatient from any source and if a person presents for treatment of injuries related to domestic violence; or if one has knowledge of or observes a child who one knows or reasonably suspects is the victim of child abuse; or if one has knowledge of, or reasonably suspects that an elder or a dependent adult is the victim of elder/dependent adult abuse.
Non-health practitioners who suspect that an individual is a victim of abuse as outlined above, are strongly encouraged to report their suspicions to a health practitioner.
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.