Senior Clinical Research Associate Job Listing at Kelly Services in Stafford, TX (Job ID 10140896)

Description

Senior Clinical Research Associate  

• Opportunity: Direct Hire / Full Time
• Schedule: Monday – Friday, 8:00 AM – 5:00 PM; preferred Western region of USA
• Location: Fully Remote
• Salary Range: $120,000.00 - $125,000.00 annually; 12% annual bonus potential
• Travel: Willingness to travel up to 75%

Kelly Science and Clinical is hiring a Sr CRA for one of our clinical-stage biopharmaceutical clients who is dedicated to advancing immunotherapy innovations. Join our client and shape the future of cancer immunotherapy; one patient at a time!

As a Senior Clinical Research Associate, you will play a key role in supporting Clinical Operations by ensuring site management and monitoring activities comply with GCP guidelines, regulations, and SOPs:

• Site Management: Support clinical trial site feasibility and site selection processes.
• Monitoring: Conduct all aspects of clinical monitoring, including site qualification, initiation, routine monitoring, and close-out visits.
• Documentation: Support the maintenance of Investigator Site Files and sponsor Trial Master Files (eTMF).
• Reporting: Prepare accurate and timely trip visit reports.
• Trial Oversight: Review progress of clinical trials, especially patient recruitment and data capture, and initiate appropriate actions to achieve objectives.
• Collaboration: Participate in regular clinical trial team meetings and act as the primary contact for clinical trial supplies and vendors.
• Presentations: Organize and make presentations at Investigator Meetings.

Secondary Functions:

• Mentor less experienced or new CRA colleagues.
• Perform Clinical Trial Manager (CTM) tasks as appropriate and as delegated.
• Contribute to continuous improvement of Clinical Operation processes and templates.

Required Experience and Education

• Education: Minimum Bachelor's Degree, preferably in life science or nursing, or equivalent.
• Experience: At least 4 years of on-site monitoring experience in the pharmaceutical or biotechnology industry (including all monitoring visit types).
• Required experience monitoring oncology trials focused on cell therapy such as but not limited to CAR-T, melanoma, and gynecology cancers to name a few focused areas
• Phase III experience is required  
• Compliance: In-depth knowledge of ICH-GCP, FDA, and EMA and applicable local regulations and laws.
• Technical Skills: Demonstrated computer skills, including Microsoft Office and clinical trial systems such as eTMF and CTMS.
• Soft Skills: Exceptional attention to detail and advanced presentation and organizational skills.
• Authorization: Legal eligibility to work in the United States is required.

Our client believes in investing in their team's health, safety, and well-being

• Comprehensive Benefits: Competitive rates for Health, Dental, and Vision Insurance.
• Paid Time Off: 4 weeks of PTO (granted up front), 56 hours of Sick Time, and 12 Paid Holidays.
• Financial Security: 401(k) with immediate eligibility and company match (up to 5% based on tenure).
• Insurance: 100% employer-paid Life Insurance and Short- and Long-Term Disability coverage.
• Growth: Opportunities to work with leading experts in the field of T-cell immunotherapy and company-provided learning and development opportunities.

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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