Medical Protocol Writer-SOM: Office of Clinical Research-Sacramento Campus
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.
Final Filing Date : 12/17/20
Salary Range : $2,613.03 to $5,245.21
Salary Frequency : Bi-weekly
Appointment Type : Career
Percentage of Time : 100
Shift Hour : Day
Location : Cancer Center, Office of Clinical Research
City : Sacramento
Union Representation : No
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.
The Medical Protocol Writer is a health professional who possesses analytical and communication skills, knowledge of FDA/GCP/NIH guidelines, knowledge of IRB policies and procedures and a willingness to cooperate as a team member. The Medical Protocol Writer performs protocol management of the Cancer Center's Investigator-Initiated trials (IITs) from concept development, through scientific and regulatory approvals, to activation of the trials. Position serves as the technical expert in all aspects of Investigator Initiated Trial (IIT) portfolio management to ensure that safety is the highest priority and that trials are developed in accordance with FDA guidance and reporting mandates.
Advance and extensive knowledge of FDA/GCP/NIH guidelines; IRB policies and procedures
Advanced knowledge and understanding of oncology and disease processes as applied to clinical research
Advance and extensive knowledge of clinical research trials regulations (e.g., Food and Drug Administration [FDA] and Office for Human Research Protections [OHRP])
Strong analytical, administrative, and communication skills and ability to exercise good judgment, initiative and resourcefulness
Extensive experience analyzing and interpreting federal, local, and institutional regulatory changes
Demonstrated strong organizational skills and attention to detail so that large volumes of records can be accurately maintained to accomplish a task or goal
Advanced knowledge of medical terminology
Working knowledge and experience with Microsoft Word, Excel; skill to learn eResearch (Velos database) to perform certain functions
Strong communication skills to effectively communicate both orally and in writing with a wide diverse group of individuals using a variety of channels
Master's degree in Biology, Molecular Oncology or related field and/or equivalent experience/training.
Clinical Research certification (SOCRA, ACRP)
Ph.D. in Biology, Molecular Oncology or related field.
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.
The University of California is an Equal Opportunity/Affirmative ction 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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