Senior Clinical Research Associate - East coast - Kelly Services
Raleigh, NC 27560
About the Job
Senior Clinical Research Associate - East Coast
Kelly Science and Clinical FSP is currently seeking a Senior Clinical Research Associate for a long-term engagement in the US with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Summary:
This individual will be responsible for managing clinical activities at study sites conducting studies for the Medical Devices group, as well as, fostering strong, productive relationships with colleagues within the Medical Devices Group.
Responsibilities:
Responsible for managing clinical study activities for multiple sites in single or several clinical projects. Oversees performance of appointed study sites, conducting company initiated clinical studies. Responsible for the site visits, monitoring, communication, and deliverables for the assigned study sites. Serves as a member of the clinical study team and is the liaison between the clinical study team and study site personnel for the specific clinical projects.
Clinical Study Site Management Tasks:
Verify safety and well being of study subjects are maintained for assigned study sites.
Support the operational execution of clinical trials and ensure collection of high quality, substantiated data.
Execute clinical trials activities following established standard operating procedures, good clinical practices and regulatory requirements.
- Accountable for study site performance, and providing high quality data according to overall project timeline.
- Assist Clinical Operations staff and study site staff to quickly and effectively resolve issues. Responds to problems and assists in implementing corrective and preventive actions, if required.
Verify Investigator Site Files at assigned study sites are maintained according to regulations and/or company requirements/procedures.
Responsible for supporting patient recruitment and retention activities.
Performs site visits and ensures study site is compliant with the study protocol and all Federal, State, local, and company regulations, policies and procedures.
Assists with internal communication of important clinical data and events.
Support organization of Investigator and other study training meetings, if required.
Functions as a reliable, trusted resource of accurate, up-to-date study site status knowledge, as requested by key stakeholders.
Understand business value of clinical projects and balances overall business objectives and functional needs.
May be involved in other tasks to support Clinical Operations and Operating Company as needed.
Support the implementation of new clinical systems/processes.
Interface and collaborate with Investigators, IRBs/ECs, contractors/vendors, and company personnel as needed.
Previous clinical research experience required.
Previous medical device monitoring or equivalent experience required.
Requires understanding and application of regulations and standards applied in clinical research areas and medical devices/combination products.
Relevant industry certifications preferred (i.e., CCRA, RAC, CDE).
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 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.