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1+ months

Site Manager or Director of Operations

Kelly Services
Oakland, CA 94606
**Site Manager or Director of Operations**


Responsible for providing leadership and direction for the clinical trials units including strategic planning and operational structure. Ensure policies and procedures are optimal, continuously reviewed, well-articulated to the user community and available in written and electronic format. Establish strong functional relationships with all units participating in sponsored clinical research and ensure the clinical efforts are closely coordinated with the Administrative, Regulatory, Outreach, Training, and Quality Assurance departments. Manage the research activities at the assigned site while working closely with the CEO and President to establish the clinical units, assuring clinical research activities are fully compliant with federal guidelines and meet the standards of industry expectations. Ensure staff members are appropriately trained and fully supportive of company mission. Optimize operations including information technology, to minimize time-to-completion and maximize rapidity of communication with investigators, IRB office and sponsors. Manage the research activities at assigned site. Provide current information, announcements, advisories, etc. to all clinical sites. Serve as principal information source for site. Work is normally performed in a typical interior/office work environment.


**Responsibilities and Essential Duties**


**Daily**


+ Conducts management activities in a professional and educational manner.

+ Pre-Study and Pipeline

+ Determine feasibility of facility to conduct the study in accordance to protocol requirements.

+ Oversees the coordination of departments for protocol execution.

+ Collects clinic demographics and reviews site questionnaires for pipeline studies.

+ Coordinates with the business development team and senior leadership on projects/proposals

+ Manages the execution of contracts.


**Post Site Selection Activity**


+ Develop recruitment strategies and formalize recruitment plans collaboratively with study team and investigator(s)

+ In conjunction with the Senior Study Coordinator, assigns research study based on workload, study protocol complexity, and skills/knowledge base.

+ Assigns ancillary personnel involved in assisting study coordinators in the implementation and evaluation of clinical studies.

+ Facilitates required training and education programs for each protocol.

+ Facilitates communications within site to ensure dissemination of organizational information and serves as principal information source for site.

+ Facilitates weekly staff meetings to ensure efficiency and smooth operations of all studies between the coordinators, raters, and clinical support staff as well as the departments and clinical units they interface.

+ Provides routine site reports identifying coordinator work load, study progress, and infrastructure needs to support assigned studies.

+ Works closely with and reports to the VP of Operations to establish the site as an exemplary component of the company.


**Study Execution**


+ Monitors recruitment, enrollment, execution and retention of enrolled patients.

+ Identifies and maintains compliance with all federal, state, and professional regulatory standards as issued through OSHA, FDA, and ICH for each study.

+ Ensures compliance with protocol guidelines and requirements of regulatory agencies including HIPAA regulations and applicable law.

+ Monitor study conduct problems and/or inconsistencies; provide corrective action as appropriate.

+ Facilitates accurate and timely data collection, documentation, entry and reporting for all assigned studies.

+ Coordinates all monitoring and auditing activities.

+ Evaluates and interprets study progress/trends and provides appropriate recommendations or conclusions for study conduct improvement.


**Minimum Qualifications:**


**Education** **:**


+ Minimum of a Bachelor's degree

+ Masters degree preferred; exceptions may be made based on experience


**Experience** :


+ Minimum of 10 years clinical research experience required

+ Minimum of 3 years previous quality assurance experience required.


**Skills**


+ Must be detail oriented, well organized, and can work independently


+ Ability to comprehend multiple clinical trial protocols

+ Knowledge and experience with audit techniques

+ Excellent written and oral communication


**Specialized Skills:**


+ Demonstrated leadership, organization, and supervisory skills.

+ Strong knowledge of GCP, ICH, regulatory and organizational standards.


**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. 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-01-18 Expires: 2021-03-04

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Site Manager or Director of Operations

Kelly Services
Oakland, CA 94606

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