Senior Clinical Research Coordinator- SOM: Stem Cell Department- Sacramento Campus
The UC Davis Alpha Stem Cell Clinic (ASCC) specializes in early phase, first-in-human trials. The Alpha Stem Cell Clinic is devoted to accelerating the translation of all types of stem cell and regenerative medicine research to safe and effective therapies. It attracts patients, funding agencies and study sponsors to participate in, support, and accelerate novel cell and gene therapy clinical trials and ancillary studies for a range of difficult diseases.
Job Summary Final Filing Date : 12/5/20 Salary Range : $34.18 to $54.97 Salary Frequency : Hourly Appointment Type : Career Percentage of Time : 100% Shift Hour : Varied Location : Alpha Stem Cell Clinic 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 Sr. CRC is responsible for Regulatory and Data management of studies assigned. The Alpha Stem Cell Clinic is a wide-ranging collaboration with unique contributions launched by the California Institute for Regenerative Medicine (CIRM) through the Alpha Clinic and other grants. Under general direction of Clinical Research Supervisor, the Senior Clinical Research Coordinator has an advance-level working knowledge of data management activities, excellent communication skills and ability to work in a team environment to independently coordinate, direct and ensure follow through for overall administration and outcome of multiple clinical studies. This position will include oversight and training of new or lower-level clinical research coordinators and/or other support personnel, coordinating research meetings and acting as a resource. This 100% position will work with the PIs, other department personnel, sponsors, and community physicians to support and provide guidance on the administration of the regulatory coordination, data management, compliance, patient navigation, personnel and other related aspects of oncology and transplant related clinical studies. This is a grant funded position.
Seven or more years of experience in Industry Sponsored clinical trial processes; clinical and regulatory.
Extensive knowledge of FDA and IRB regulations, ICH guidelines and current Good Clinical Practice (cGCP).
Three or more years of experience working with a Clinical Trial Management System; Velos or Encore.
Experience working with computer systems and databases, including Windows, Microsoft Office Suite, electronic
medical records, and electronic data capture systems for clinical research.
Communication skills to convey factual information; to engage in collaborative problem-solving and negotiation
with staff and colleagues.
Self-directed and able to work independently, meeting the scope of the program with minimal supervision and with
frequent changes in priorities and deadlines.
Ability to independently exercise judgment, initiative and resourcefulness in making decisions.
Demonstrate oral communication and interpersonal skills to effectively correspond with the general public, coworkers, physicians, patients, cargivers, clinic staff and other health care professionals.
Display organizational skills and attention to detail so that large volumes of records can be accurately maintained,
and workload priorities can be determined in an appropriate way to accomplish a task or goal. Ability to multi-task.
Ability to work cooperatively as a team in a diverse workforce.
Three or more years of experience in stem cell clinical trials.
Advanced-level knowledge of basic anatomy, medical terminology and ability to interpret physicians' notes, medical records, laboratory and scan results.
Advanced-level knowledge and understanding of oncology and disease processes as applied to clinical research.
SoCRA or ACRP Certification required
IRB CITI training
Laboratory Safety Training
IATA & 49 CFR Certificate
Must have extensive knowledge of clinical trial management.
This position will require an extended number of hours on the computer.
General operational schedule 8-5 M-F, but must be able to work a flexible schedule for patient needs.
Occasional overtime and weekends may be required.
Required travel for training and conferences.
Walking to and from different sites on the Health System campus several times per day required.
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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