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Medical Protocol Writer-SOM: Office of Clinical Research-Sacramento Campus - 10558

Company: University of California - Davis
Location: Sacramento
Posted on: November 24, 2020

Job Description:

Department Description

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 : 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.

Required Qualifications


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.

Preferred Qualifications


Clinical Research certification (SOCRA, ACRP)

Ph.D. in Biology, Molecular Oncology or related field.

Special Requirements


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..

Keywords: University of California - Davis, Sacramento , Medical Protocol Writer-SOM: Office of Clinical Research-Sacramento Campus - 10558, Advertising , Sacramento, California

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