CLINICAL RESEARCH ASSISTANT

The primary responsibility of the Clinical Research Assistant (CRA) provides support to the Clinical Research Coordinator (CRC) and Principal Investigator (PI) in conducting clinical research studies. The CRA will work closely with the CRC and research team to ensure the successful execution of clinical research studies. The research assistant should have general knowledge of protocol requirements and good clinical practice set forth by federal regulations.

Qualifications/Skills

• High School diploma required.
• Certified Medical Assistant preferred or bachelor degree in a health-related field such as biology, or public health.
• Basic knowledge of anatomy and med term preferred.
• Experience working in a clinical research environment preferred.
• Excellent organizational and communication skills.
• Ability to work independently and as part of a team.
• Proficient in using electronic data capture systems and Microsoft Office.
• Attention to detail and strong problem-solving skills.
• Strong communication skills, verbal and written

Principal Duties and Responsibilities

• Adheres to standard operating procedures (SOP),GCP, and all regulatory practices as established by law, and company policies.
• Provides assistance to research staff by organizing files, project information, and data.
• Assist with collecting training forms collection and or preparation of essential documents and obtaining required signatures from all applicable research personnel for regulatory/essential documents throughout the duration of a study including, but not limited, to Food and Drug administration (FDA) form 1572, CV, professional licensure, financial disclosure form (FDF), and Institutional Review Board (IRB) submission forms.
• Assist in the coordination of clinical research studies, including study participant recruitment, screening, and enrollment in accordance with study protocols.
• Understand this protocol specific key inclusion/exclusion criteria to assist in pre-screening efforts.
• Communicate with study participants and their families to provide study-related information and to ensure study visit schedules are met.
• Collect and manage study data in a timely and accurate manner, utilizing electronic data capture systems.
• Acquires dry ice for shipping laboratory specimens.
• Assist in the coordination and conduct of study visits, including performing study procedures, collecting specimens, and administering study questionnaires.
• Work collaboratively with the research team to troubleshoot and resolve study-related issues.
• Assist in the preparation of study materials, including pre-screening, chart prep, case report forms, study manuals, and lab preparation.
• Develops an understanding of the regulations governing the transport of human specimens by obtaining and maintaining international air transport association (IATA) certificate.
• Participate in study team meetings and attend required training and educational sessions.
• Maintain study supplies and equipment and ensure that they are stored and maintained in accordance with regulatory requirements.
• Trains under the guidance of direct supervisor and other site personnel to promote participation in research studies including mail-outs and other marketing programs as applicable.
• Assist with general managed site projects and workload sharing as assigned by direct supervisor.
• Increase completion and collection of form W9 for new research subjects.

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.
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

• Adheres to standard operating procedures (SOP),GCP, and all regulatory practices as established by law, and company policies.
• Provides assistance to research staff by organizing files, project information, and data.
• Assist with collecting training forms collection and or preparation of essential documents and obtaining required signatures from all applicable research personnel for regulatory/essential documents throughout the duration of a study including, but not limited, to Food and Drug administration (FDA) form 1572, CV, professional licensure, financial disclosure form (FDF), and Institutional Review Board (IRB) submission forms.
• Assist in the coordination of clinical research studies, including study participant recruitment, screening, and enrollment in accordance with study protocols.
• Understand this protocol specific key inclusion/exclusion criteria to assist in pre-screening efforts.
• Communicate with study participants and their families to provide study-related information and to ensure study visit schedules are met.
• Collect and manage study data in a timely and accurate manner, utilizing electronic data capture systems.
• Acquires dry ice for shipping laboratory specimens.
• Assist in the coordination and conduct of study visits, including performing study procedures, collecting specimens, and administering study questionnaires.
• Work collaboratively with the research team to troubleshoot and resolve study-related issues.
• Assist in the preparation of study materials, including pre-screening, chart prep, case report forms, study manuals, and lab preparation.
• Develops an understanding of the regulations governing the transport of human specimens by obtaining and maintaining international air transport association (IATA) certificate.
• Participate in study team meetings and attend required training and educational sessions.
• Maintain study supplies and equipment and ensure that they are stored and maintained in accordance with regulatory requirements.
• Trains under the guidance of direct supervisor and other site personnel to promote participation in research studies including mail-outs and other marketing programs as applicable.
• Assist with general managed site projects and workload sharing as assigned by direct supervisor.
• Increase completion and collection of form W9 for new research subjects