Sr. Clinical Research Coordinator

2 weeks ago

Irving, United States Kelly Services Full time

Kelly Science & Clinical® is working with a Clinical Research Site Network with an immediate need for an experienced Clinical Research Coordinator with site leadership experience for the Dallas Metro area. 

Position: Clinical Research Coordinator III (Full-Time/Non-Exempt): On-Site

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.

Reports to: Site Lead/Manager
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


Required Skills/Abilities:


Experience leading 6-8 studies preferred
Ability to work independently and as a member of a team


Education and Experience:
 


GED or HS Diploma required (Some College preferred)
5+ years clinical research experience required


Physical Requirements:


Must be able to work remotely and be available during business hours
Must be able to lift up to 15 pounds at times





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.
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