Clinical Research Site Operation Leader

Job Description

Job Description

Clinical Site Operation Manager

• Employment: Direct Hire/Permanent, Fulltime, M-F, Onsite
• Location: Inglewood, CA (Must be onsite)
• Salary: $90 - $110k annually (Additional quarterly bonus opportunity that would significantly add to yearly income)

Kelly Science and Clinical is hiring a Clinical Operations Manager for one of our growing clinical research site networks. This person will oversee the day-to-day functions of the clinic, manage the office personnel, as well as manage daily operational and administrative activities. This individual will act as a liaison between patients, medical staff, clinic staff, and management to ensure optimal clinic functioning. Additionally, the Manager will play an essential role in ensuring policies and procedures, ensure that the clinic delivers exceptional patient care, and function efficiently.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manage and train clinic site personnel.
• Identify and implement strategies to expand the research capabilities at the site - in line with the overall site business plan.
• Oversee the implementation and maintenance of quality standards at the site ensuring that the conduct of clinical studies and the collection of patient data is in accordance with ICH GCPs.
• Manage Site Budgets / Expenses
• Work with the Medical Director/PI to address any study and/or clinical quality related matters.
• Ensure timely and appropriate communications occur with Sponsors and IRBs, as necessary.
• Develop site staffing plans to ensure the successful and efficient conduct of research studies. Identify and fulfil any site resource needs which are necessary to successfully conduct and/or recruit research studies.
• Oversee the development of the patient recruitment plan and patient outreach process. Make ongoing adjustments/modifications to recruitment strategies based upon the timely review of results to ensure financial and study-specific targets. Closely collaborate with any external vendors to facilitate successful patient enrollment strategies.
• Read, comprehend, and communicate study protocols and oversee SIV, PSDV and IMV.
• Manage and facilitate study startup documentation, training, supplies and timelines of study protocols.
• Develop and implement operational plans, timelines, and budgets for clinical trials.
• Monitor study progress, resolve data issues, and prepare status reports for leadership.
• Work closely with CRO/CRA/IRB.
• Maintain site regulatory files.
• Document temperatures for IP stored on-site.
• Audit study e-source documentation to comply with study protocols.
• Support audits and inspections
• Monitor study metrics and key performance indicators (KPIs)
• Perform other duties as assigned.

EDUCATION and EXPERIENCE:

• Bachelor’s degree preferred in healthcare or equivalent clinical research experience.
• 5+ years of clinical management experience
• 3 years' experience working as a Clinical Research Coordinator, required.
• Comprehensive knowledge of FDA, GCP & confidentiality.
• Proven success in managing teams and working in direct patient care, required.
• Proficient problem-solving skills & conflict resolution.
• Proficient in Microsoft Word, Excel and PDF.
• Excellent verbal and written communication skills.
• A proven ability to constantly prioritize multiple projects in a rapidly changing environment.
• Must be comfortable with a rapid-growth company.
• Monitor project timelines and ensure milestones are met

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals-it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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