Description
Kelly® Science & Clinical is seeking a CRC III for a permanent position at cutting-edge client in Burke, VA. 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.
Location:
Burke, VA
Company Overview:
The client is a growth-oriented research company committed to the excellent conduct of clinical trials. They are team-oriented and centered on core values, focusing on Focus, Discipline, and Accountability. The client does excellent work and are Making Life Better for their clients and participants.
Position:
Clinical Research Coordinator III
Responsible for the overall management the studies assigned to you including administrative duties, such as regulatory functions. Responsible for clear and direct communication with study sponsor, study monitor and CRO, PI and site manager. Adherence to site SOPs is required.
Job Description:
The Clinical Research Coordinator (CRC III) manages the daily operations of assigned clinical trials. It is the responsibility of the CRC III to communicate with the investigator, sponsor and study participants all necessary information of the study. It is the responsibility of the CRC III to problem solve issues that may arise and to represent himself/herself and the site in the most professional, ethical and positive manner.
- Inform study participants or caregivers about study procedures and outcomes to be expected
- Train study team members and monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies
- Have all source documentation filled out and completed while the study participants visit is occurring and while the study participant is on site for optimal accuracy of data collection
- Have all source documentation completed, entered into EDC within 48 hours of study participants visit
- Inventory lab and study supplies. Order supplies or delegate to Research Assistant to order needed supplies
- Attend investigator meetings with principle investigator: asks questions and collects pertinent study information while at investigator meeting
- Attend site initiation visits from various drug sponsors and conduct site initiation tours
- Confer with business/recruitment department to determine the best recruitment practices for studies
- Maintain required records of study activity including case report forms, drug dispensation records
- Communicate with laboratories or investigators regarding laboratory findings
- Order drugs or devices necessary for study completion
- Direct the requisition, collection, labeling, storage, or shipment of specimens
- Perform specific protocol procedures such as interviewing study participants, taking vital signs, performing electrocardiograms and taking laboratory specimens
- Record adverse event and side effect data and confer with investigators regarding the reporting of events to sponsors
- Maintain contact with sponsors to schedule and coordinate site visits/monitoring visits
- Resolve all auto queries in the EDC within 24 hours of query being issued by sponsor
- Dispense medical devices or drugs, and calculate dosages, drug compliance and provide instructions as necessary
- Drug Accountability. Logging new medication shipments and reporting to sponsor received and if lost or damaged. Logging dispensed medication to study participants in appropriate medication log
- Initiate and maintain accurate master logs for each study. (ICF, patient ID, and enrollment)
- Prepare for or participate in quality assurance audits
- Label and organize space for drug. All drug received should be put in drug cabinets immediately once drug arrives to site after being checked in and logged into the drug logs
- Maintain accurate temperature logs daily as needed
- Prepare study participants source documents prior to patient visit
- Maintain training logs on all up-to-date studies
- Maintain and update study delegation logs
- Maintains all safety reports for all studies. Make sure that PI is aware of safety reports to be completed and signs off in a timely manner
- Functions as a subject matter expert in the area of Clinical Research to provide support and guidance for peers
- Other duties as assigned
- Experience leading 6-8 studies preferred
- Ability to work independently and as a member of a team
- GED or HS Diploma required (Some College preferred)
- 5+ years clinical research experience required
- Must be able to work remotely and be available during business hours
- Must be able to lift up to 15 pounds at times
#P1
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. 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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