Senior Clinical Research Associate Job Listing at Kelly Services in Golden Valley, MN (Job ID US3551844_BH9787877)

Description

Device Sr CRA
Minneapolis MN
 

• Location: On-site in Minneapolis, MN
• Travel expectations: Around 30%
• Opportunity: Direct Hire with our client
• Salary: Salary will depend on level/years of experience and other factors such as location and class III medical device experience. Salary range could be 120,000 - 140,000 annually

Kelly Science and Clinical is hiring for one of our MN clients who is looking for a senior level In-house CRA to join their team. Our biotech client is committed to enhancing patients' lives through medical device innovations. They prioritize patient outcomes, act with integrity and lead with respect.
 
ESSENTIAL JOB FUNCTIONS
We are recruiting for a Senior Clinical Research Associate to join our team. In this role, you will be responsible for the initiation and oversight of clinical centers to ensure the successful conduct of active clinical studies. You will also ensure that clinical centers perform clinical studies according to the study protocol and regulatory standards by qualifying, training, monitoring and overseeing study conduct at multiple clinical centers.

OPPORTUNITIES YOU WILL HAVE IN THIS ROLE  

• Identify and assess the suitability of clinical study centers for participation in clinical trials
• Train clinical centers on the clinical study protocol, data collection and good clinical practices
• Site Management: Communicate directly with clinical centers to maximize enrollment, ensure quality and timely data capture and answer study-related questions
• Assist in mentoring Junior monitors
• Perform remote and on-site monitoring visits at participating clinical study centers to ensure the safety of study patients, the reporting of accurate study data and appropriate study management at the clinical study center
• Document site visits by preparing visit reports and follow-up letters to the clinical study centers
• Assist clinical centers with the preparation of IRB/EC submissions
• Collect and archive study related documentation and correspondence
• Communicate monitoring and site management updates to the internal clinical team
• Assist with the development of the clinical study Monitoring Plan
• Develop training materials and other study-related documentation
• Maintain clinical monitoring tracking tools for each clinical study
• Assist with other clinical related duties as assigned
• Document product and therapy field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed
• Complete training requirements and competency confirmations as required for this position within the required timeline
• Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement

Required Qualifications:

• Bachelor's Degree (BA or BS) - Science Degree preferred
• Implantable medical device experience preferred – Class III Device Monitoring required
• 8+ yrs of clinical research experience, including experience with clinical study documentation, clinical data and data capture institutional review boards
• Previous training and understanding of GCP and 21 CFR 812 
• Ability to report on-site to Golden Valley, MN office 
• Ability to travel up to 30% 

BENEFITS AND OTHER COMPENSATION

• Multiple health insurance plan options. 
• Employer contributions to Health Savings Account.
• Dental, Vision, Life and Disability benefits.
• 401k plan + employer match.
• Identity Protection.
• Flexible time off. 
• Tuition Reimbursement.
• Employee Assistance program.
• All employees have the opportunity to participate in the ownership and success of our clients. Employees at all levels can participate through equity awards and the Employee Stock Purchase Program.

 

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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