Description
PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship. For immediate consideration, please apply.
Kelly® Science & Clinical is seeking a Clinical Research Analyst for a temporary position (with potential to extend/covert) at a leading client in East Point, GA. 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.
Pay Rate:
$30.00/Hour (non-negotiable)
Overview:
As an independent clinical research site, our client is dedicated to diversity with excellence in conducting clinical research. They are a passionate, caring, multi-disciplinary team conducting clinical research with expertise and compassion, and always to the highest ethical standards.
Our client looking for a Clinical Research Coordinator with at least 5 years' experience in clinical research to join our motivated research team. The right candidate must have prior clinical research experience conducting investigational clinical trials and is already familiar with clinical research workflows, regulatory requirements, and data collection and documentation practices.
Schedule:
Friday – Monday, 1st/Day: 8:30/9:00 AM – 530/6:00 PM
Responsibilities:
• Assists Principal Investigator (PI) in protection of the rights and welfare of all human research participants involved in research in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
• Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.
• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Collects documents needed to initiate the study and submit to the sponsor (e.g., Form FDA 1572, CVs, etc.).
• Works with the PI to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.
• Conducts or participates in the informed consent process including interactions with the HRPO (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
• Performs safety and efficacy assessments per study protocol.
• Collect or coordinate collection of clinical procedures such as vital signs, ECGs, blood draws, IP infusions, PFTs.
• Responsible for timely data entry and query resolutions.
• Reports study findings, such as serious adverse events (SAEs) or protocol deviations (PDs) to the applicable department, such as the sponsor or IRB.
• Manages participant chart binders and coordinates accurate completion of source with various delegated staff.
• Follows participants from the start to end of study participation and escalates safety concerns to appropriate individuals, such as the PI or Medical Monitor.
• Prepare study data for interim monitoring visits and meet with study monitor to follow-up on resolving queries/issues.
• Communicate with sponsors, CROs, vendors, or other representatives promptly and professionally.
• Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
• Updates source documents per study protocol amendment.
• Coordinate operations with other departments to facilitate completion of procedures during participant visits, includes communications with nurse practitioners, medical assistants, pharmacy, regulatory, and/or physical therapy.
• Retains all study records in accordance with sponsor requirements.
• Works with the PI and study-specific RAs to manage the day-to-day activities of the study including problem solving, communication, and protocol management.
• Ability to exercise independent judgment and discretion.
The above statements are intended only to describe the general nature of the job and should not be construed as an all-inclusive list of position responsibilities.
Qualifications:
• BA/BS in business, social science, health science or related field required.
• Alternative educational backgrounds may be accepted (i.e., LPN, Medical Assistant, etc.) in combination with previous CRC experience.
• Must have GCP, IATA, ALCOA-C training.
• BLS/CPR training upon hire date.
• Must have at least 5 years of experience in the clinical research field.
• Previous experience as a CRC.
• Phlebotomy Experience.
• Strong attention to detail and organizational skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
What Happens Next:
Once you apply, you'll proceed to next steps if your skills and experience look like a good fit. But don't worry – even if this position doesn't work out, you're still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.
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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