Senior Clinical Research Coordinator

Clinical Research Coordinator III McKinney, TX

Kelly Science & Clinical® is hiring a Sr Clinical Research Coordinator for one of our growing clients who is a Clinical Research Site Network.

This is a direct hire opportunity to join a multi-site network that is growing across the US.

In this position, you will be accountable for the comprehensive oversight of clinical studies, encompassing both administrative tasks and regulatory responsibilities.

Ensures clear and direct communication with the study sponsor, study monitor, CRO, PI, and site manager. Compliance with site SOPs is mandatory.

The Clinical Research Coordinator (CRC III) oversees the daily operations of assigned clinical trials. The CRC III is responsible for conveying all essential study information to the investigator, sponsor, and study participants.

Additionally, the CRC III must address and resolve any issues that arise, while representing themselves and the site in a professional, ethical, and positive manner.

• Inform study participants or caregivers about study procedures and anticipated outcomes.
• Train study team members and monitor study activities to ensure adherence to protocols and all relevant local, federal, and state regulatory and institutional policies.
• Complete source documentation during the study participants' visit on-site to ensure optimal accuracy of data collection.
• Enter completed source documentation into the EDC within 48 hours of the study participants' visit.
• Inventory lab and study supplies, and order supplies or delegate the task to a Research Assistant as needed.
• Attend investigator meetings with the principal investigator, ask questions, and collect relevant study information.
• Attend site initiation visits from various drug sponsors and conduct site initiation tours.
• Confer with the business / recruitment department to identify the best recruitment practices for studies.
• Maintain required records of study activities, including case report forms and 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 collecting laboratory specimens.
• Record adverse event and side effect data, and confer with investigators about reporting 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 the query being issued by the sponsor.
• Dispense medical devices or drugs, calculate dosages, monitor drug compliance, and provide instructions as necessary.
• Maintain drug accountability by logging new medication shipments, reporting any received or lost / damaged shipments to the sponsor, and logging dispensed medication to study participants in the appropriate medication log.
• Initiate and maintain accurate master logs for each study, including ICF, patient ID, and enrollment logs.
• Prepare for or participate in quality assurance audits.
• Label and organize space for drugs, ensuring all received drugs are placed in drug cabinets immediately after being checked in and logged.
• Maintain accurate daily temperature logs as needed.
• Prepare study participants' source documents prior to patient visits.
• Maintain up-to-date training logs for all studies.
• Maintain and update study delegation logs.
• Retain all safety reports for all studies, ensuring the PI is aware of safety reports that require completion and timely sign-off.
• Function as a subject matter expert in Clinical Research to provide support and guidance to peers.
• Other duties as assigned Requirements :
• GED or HS Diploma required (Some College preferred)
• 5+ years clinical research experience required
• Experience leading 6-8 studies preferred
• Ability to work independently and as a member of a team

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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