Our physicians conduct clinical research and collaborate closely with laboratory scientists, ensuring that new drugs, advanced biotechnologies and other treatments developed in the lab can move quickly to the clinic to benefit patients. Job Summary Final Filing Date : 8/20/2021 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 Responsibilities The Senior Regulatory Clinical Research 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. Also required is advanced-level knowledge of federal, local, and institutional regulatory guidelines. This position will provide leadership for a department-wide clinical research program, including mentoring and overseeing junior regulatory coordinators and/or other support personnel. Occasional travel and overtime will be required. Required Qualifications
- 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 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
- Experience with Microsoft Office Suite: Word, Excel, Outlook, Access, etc.
- Experience with 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.
- Ability to travel on occasion.
- Previous experience coordinating oncology clinical trials.
- Certification by the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP)
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.
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