23 days old

Clinical Research Coordinator- University Oncology Center

Kelly Services
Sacramento, CA 94278
CRC roles at our UC Cancer Center are specialists and support specific groups: Clinical Operations, Regulatory Affairs, or Data Management.

**CRC-Data Management**

**Summary of Responsibilities**

Following University, Federal and sponsor guidelines, perform case management, clinical treatment and follow-up care of patients on protocols. This may include, but is not limited to, one or more of the following:

a. Ensuring patient safety by entering timely data

b. Interpreting the protocol and advising the treating physician regarding reportable requirements;

c. Assessing and documenting side effects related to study treatment;

d. Acquiring, de-identifying, and transmitting study procedures to appropriate vendors

e. Managing monitor, data management, and safety queries as well as data cuts;

f. Assist investigators and other health care professionals in evaluating compliance to protocol requirements while participating in the process of deviation reporting/corrective action plans if needed;

g. Tracking/contacting patients for long term follow up protocols

h. Upon protocol activation, assist in identifying unique data requirements where specialized source/processes are needed;

i. Perform investigator initiated trial audits; aid in providing audit finding responses

j. Abstract data from necessary source documentation to complete flow sheets, case report forms, regulatory, CTSU database and other documents required by the sponsor.

**Additional Tasks**

Instruct sponsor representatives in cancer center, OCR standard operating procedures and facilitate source data verification. This may include, but is not limited to, one or more of the following:

a. Managing physician connect access, training, and compliance for sponsor monitors and auditors;

b. Scheduling monitors and auditors and facilitating their visits to ensure contract compliance;

c. Serving as a liaison between physicians and sponsors regarding protocol details and patient updates;

d. Facilitating close out visits

e. Archiving IRB closed studies

**Regulatory Duties:**

+ Assist in submitting annual FDA IND reports and quarterly sponsor SAE reconciliations.

+ Verify the accurate preparation of amendments, modifications, and revisions

+ Report serious adverse events and deviations according to study sponsor, FDA, NCI, and Human Subjects Review Committee guidelines

**Other tasks:**

+ Assist in invoicing for line items of clinical trials. Organize and provide suggestions as to work priorities. Assist with work procedures to be performed. Participate in the interview and selection process of new personnel and participate in actions for improvements.

+ Prepare for and assist during audits, including evaluating protocol study forms for completeness, accuracy and compliance to protocol, performing consistency checks, editing for errors and gathering records, reports, radiographs, scans and other necessary materials required for institutional site audits.

+ Attend sponsor group meetings;.

+ Foster and maintain cooperative relationships with other institutional departments, Federal sponsors, and co-workers.

+ Participate in continuing educational activities; attend meetings, and conferences relevant to oncology and clinical trials; attend seminars and conferences related to the field of clinical research; and attend courses related

**Why Kelly** **** **?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (
Posted: 2021-04-19 Expires: 2021-05-20

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Clinical Research Coordinator- University Oncology Center

Kelly Services
Sacramento, CA 94278

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