Clinical Trial Associate Job Listing at Kelly Services in Santa Clara, CA (Job ID 9387485)

Description

Kelly® Science & Clinical is seeking a Clinical Trial Associate for a part time, contract position with a Medical Device start-up in Santa Clara, CA. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

• Part-time, about 20 hours per week (some potential to go full-time)
• Flexible hours, onsite
• $35.00 hour
• No C2C

Clinical Trial Associate

The Clinical Trial Associate will be located in-office and, under supervision, will support the Clinical Affairs department in the conduct of clinical research studies (IDE/Post-Approval/Post-Market) sponsored by our client. This person will support the clinical studies by assembling and distributing clinical study materials; maintenance of the Trial Master File; collecting, filing and tracking regulatory documents related to clinical studies; tracking IRB/EC approvals and renewal dates; support device accountability and shipments. The Clinical Trial Associate will also help with other essential day-to-day functions to ensure study success from a study administration perspective. This position requires, strong communication skills (oral and written), ability to work independently, and the ability to deliver on clinical projects in a fast-paced environment.

• Updates and maintains the study Trial Master File (TMF) and supports clinical personnel by keeping the TMF and all study files current.
• Manage device accountability activities, including shipping and receiving.
• Leads the preparation of study materials for site initiation visits (e.g., study binders) and materials for ongoing study conduct (e.g., printing of source worksheets).
• Support document translations.
• Provide support to Sites and field monitoring personnel by shipping study supplies and updated binders/forms as requested.
• Support clinical affairs management with administrative activities related to Investigator and Coordinator Meeting logistics and materials.
• Assists with generating and maintaining clinical affairs related metrics for department and company needs.
• Assists clinical affairs personnel and management with administrative activities related to clinical studies, including in creation and/or submission of clinical study reports, regulatory submissions, publications, and presentations. These may include, but are not limited to IDE supplements, PMA/510k materials, IRB/EC/CA submissions.

Qualifications / experience:

• Experience with assisting/supporting a department.
• Familiar with Medical Device product trials and regulations, working knowledge of GCP a plus.
• At least 1 year experience with Trial Master File support.
• Exceptional time management skills able to multi-task and prioritize.
• Advanced oral and written communication skills.
• Proven ability to work independently and with teammates.
• Good problem-solving skills.
• Excellent communication and interpersonal skills with demonstrated ability to maintain ongoing communications with department staff, clinical study Site personnel, and other employees.
• Personal attributes: independent, decisive, accurate, detail-oriented, multi-tasking, organized, and flexible.

Additional qualifications:

• Associates Degree/College Diploma desired. Bachelor's degree in health sciences or related field preferred.
• Microsoft Office

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 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.

 Apply on company website