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Clinical Research Study Start Up Manager

Position: Clinical Research Start-Up Manager - Hybrid

Job description : The Clinical Research Start-Up Manager is an experience clinical trial research professional with research-specific knowledge and skills, who has general responsibility for managing clinical trials for the Research System . The Clinical Trial Start-Up Manager will train 5 to 6 local sites that are new to clinical trials. The training will work toward providing the sites guidance to be able to conduct their trials independently from start-up through follow-up and close-out.

**ensures the integrity and quality of clinical trials are maintained and conducted in accordance with federal, state, and local regulations, Institutional Review Board IRB requirements, and WRI policies and procedures. Utilizing the nursing process, the RN Research Coordinator is primarily responsible for coordinating clinical trials in a manner that holds the protection of human subjects as the most important principle.

Role and responsibilities:

• Area of focus: Asthma Clinical Trials

• Will require Site Visits across 5-6 Sites in and around the Brooklyn area

• Support Principal Investigator at the site

• Debrief Principal Investigator

• Train Sites:

• Feasibility

• Start-Up

• Patient Recruiting

• EDC

• Follow-Up

• Close-Out

• Query resolution

• IRB Submissions

• AE/SAE reporting

JOB QUALIFICATIONS:

• Minimum requirements to be considered qualified to do the job.

• Required Minimum Education: Bachelor’s Degree

• 5 years of clinical research experience including Start-Up and Site Management

• 25% Travel: Brooklyn, Rockland, and Westchester

• Regulatory background and experience

• Patient Recruiting

• Experience working with IRB

• EDC experience

• Minimum Certification :

• GCP Certification

• Minimum Skills :

• Strong computer skills; good oral and written communication skills; excellent interpersonal and organization skills.

• Possess excellent time management skills

If you have 5 years of Clinical Research Experience including Lead Clinical Research Coordinator and Site Manager and reside in the Brooklyn Area - APPLY TODAY!

Kelly Science & Clinical® is working with a growing clinical research network based out of Brooklyn, New York with an immediate need for a Clinical Research Start Up Manager for their clinical trials.

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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s 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.