18 days old

Clinical Research Associate - San Diego, CA

Kelly Services
San Diego, CA 92108
**Clinical Research Associate - San Diego, CA**

Every day Kelly Scientific Resources (KSR) connects scientific professionals with opportunities to advance their careers. We currently have an exciting opportunity for a **Clinical Research Associate** to work with an establish company in San Diego, CA.

+ This will start off as a In House position but must be willing to travel up to 40% to West Coast, US in the future

+ Must have a minimum of 1-2 years experience in Oncology Clinical Trials

**Duties and Responsibilities:**

+ Assist in overseeing clinical trials from initiation, planning, execution, maintenance and close-out.

+ Coordinate investigational site startup activities, including the creation, preparation, and shipment of documentation (e.g., ICFs, CRFs, study manuals, study binders, etc.), Ethics Committee submissions and approvals, reviewing/approving Essential document packages, reviewing site changes to ICFs, facilitating completion of clinical study agreements and budgets, and shipment of clinical supplies.

+ Coordinate contract vendors and Clinical Research Organization activities to ensure all are conducted according to study plans, timelines, budgets, and relevant SOPs.

+ Review invoices from vendors/consultants as per contract. Coordinate and maintain relevant tracking systems for subject screening, enrollment, study visits, data entry, query resolution.

+ Review and approve Site selection/Visit reports: Qualification Visits, Initiation Visit Reports and Interim Monitoring Visit Reports on an ongoing basis.

+ Participate in Site Initiation Visits.

+ Conduct co-monitoring visits to oversee CRO personnel and study conduct at the site. Support in the review of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IxRS specification process and UAT.

+ Assist in the planning of Investigator Meetings and/or Site and CRA trainings.

+ Assist with protocol, case report form, source document template development, internal SOP/guideline development, final report preparation.

+ Review clinical databases on a real time basis to identify/resolve data entry issues, tracks the query process to identify/report evolving trends in the data.

+ Coordinate the oversight of sample collection (i.e., tissue samples, lab samples, scans, PK samples).

+ Coordinate the exchange of TMF documents with external service providers as applicable and periodic reviews and QC of the Trial Master File to ensure audit and inspection readiness.

+ Serve as a liaison and resource for investigational sites. Additional Operations activities may be assigned as appropriate.

+ Travel as required to carry out responsibilities.

+ Participate in the development, review and implementation of departmental SOPs and processes.

**Minimum Requirements:**

+ Bachelors or equivalent in a scientific or health care field required. Minimum of 2-3 years of CRA experience in the biotechnology or pharmaceutical industry required.

+ Experience in oncology clinical trial.

+ Clinical operations experience at a small or mid-size company preferred. Comfortable in a fast-paced small biotech company environment and able to adjust workload based on changing priorities.

+ Strong Knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations.

+ Excellent verbal and written communication skills.

+ Ability to collaborate and respond to changing circumstances and needs.

+ Ability to travel up to approximately 25-30%, up to 40%

**APPLY TODAY! Questions? Contact Kevin at** **or call 623-688-2142**

**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/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.


Posted: 2020-11-16 Expires: 2020-12-17

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Clinical Research Associate - San Diego, CA

Kelly Services
San Diego, CA 92108

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