PLEASE NOTE: Must be legally authorized to work in the United States for any employer without sponsorship. For immediate consideration, please apply.
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\nKelly® Science & Clinical is seeking a Clinical Research Coordinator II for a direct hire position at a leading client in San Antonio, TX. 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.
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\n Pay Rate:
\n$52-60,000/Year (commensurate with experience)
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\n Overview:
\nResponsible for the daily operations and overall management of assigned clinical trials including administrative duties and regulatory functions. Responsible for clear and direct communication with study sponsor, study monitor, CRO, PI and site management. Adherence to Company SOPs is required. The CRC II works collaboratively with the CRC I to train and guide them on Company SOPs, protocol, and regulatory compliance. It is the responsibility of the CRC II to problem solve issues that may arise and to represent himself/herself and the site in the most professional, ethical and positive manner. Reports to: Site Manager.
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\n Schedule:
\nMonday – Friday, 1st/Day: Standard Hours
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\n Responsibilities:
\n• Enrollment of clinical trials according to protocols, identifying ways to exceed enrollment goals.
\n• Confer with the recruitment department and site management to determine the best recruitment practices for assigned studies.
\n• Inform patients or caregivers about studies and associated procedures.
\n• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies.
\n• Know the contents of and maintain assigned study e-regulatory binders, self-check all binders for compliance and forward any missing documentation to binders regularly.
\n• Follow all Company work instructions, guidelines, policies, and controlled documents, assist CRC-Is as needed by providing guidance on following and applying these documents.
\n• Scheduling of study visits and monitoring schedules according to protocol and study plan.
\n• Have all source documentation completed while the patient visit is occurring and while the patient is on site for optimal accuracy and completeness of data collection. Apply relevant good documentation practices.
\n• Data collection: all source documentation completed and entered into EDC within one business day of patient visit. Ensure data queries are resolved in the EDC within 48 hours of query being issued.
\n• Inventory lab and study supplies. For assigned studies maintain an acceptable threshold of supplies required to complete study visits and meet site enrollment goals.
\n• Attend investigator meetings with principle investigator: asks questions and collect pertinent study information while at any investigator meeting.
\n• Attend site initiation visits from various drug sponsors and conduct site initiation tours.
\n• Maintenance of required records of study activity including case report forms, drug dispensation records.
\n• Perform specific protocol procedures and interpret complex medical data (i.e.: interviewing subjects, taking vital signs, performing electrocardiograms and taking laboratory specimens) as required.
\n• Communicate with laboratories or investigators regarding laboratory findings.
\n• Record adverse event data and confer with investigators regarding the reporting of events. Revised 01/15/2025.
\n• Manage study data entry, ensuring timelines are met for entry of all source data into study systems/EDC.
\n• Direct the requisition, collection, labeling, storage, or shipment of specimens.
\n• Dispense medical devices or drugs, and calculate dosages, drug compliance and provide instructions as required.
\n• Identify, report, and problem solve protocol deviations or unanticipated events.
\n• Drug Accountability. Logging investigational product shipments and reporting received as required. Thorough documentation if lost or damaged. Logging dispensed medication to subjects in appropriate medication log as required per study protocol.
\n• Initiate and maintain accurate master logs for each study. (i.e.: ICF, patient ID, and enrollment logs).
\n• Participate in quality assurance audits as required.
\n• Ensure IP management for assigned trials: Space for investigational products is labelled and organized and required. All IP is stored with restricted access immediately once the IP arrives at the site and checked in by delegated staff.
\n• Maintain assigned study training logs/Delegation logs as required.
\n• Maintain all safety reports for all studies. Confirm PI is aware of safety reports to be reviewed and that reports are signed as required by investigators.
\n• Maintain confidentiality of patient protected health information and sponsor confidential information.
\n• Other duties as assigned.
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\n Qualifications:
\nRequired Skills/Abilities:
\n• Experience leading multiple clinical trials as lead CRC preferred.
\n• Ability to work independently and as a member of a team.
\n• Ability to train and guide staff effectively and knowledgeably.
\n• Effective verbal and written communication skills.
\n• Ability to read, write, and speak English language.
\n• Knowledge of high-level medical terminology.
\n• Potential for travel to assist and train at Company sites.
\nEducation & Experience:
\n• GED or HS Diploma required (Some College preferred).
\n• 2-5 years clinical research experience required.
\n• Phlebotomy if required by state law.
\nPhysical Requirements:
\n• Prolonged periods of sitting at a desk and working on a computer.
\n• Must be able to lift up to 15 pounds at times.
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\n What Happens Next:
\nOnce 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.
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\n\t\t\t\t\n\t\t\t\tAs 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.\n\t\t\t \n\t\t\t\n\t\t\t\t
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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. \n\t\t\t \n\t\t\tInterim Healthcare is seeking an LVN for the East Houston area. This position requires great patient assessment skills and the ability to work with little direct supervision, good time management skills, good communication skills, reliable transportation.Licensed Practical...
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