This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
Our Client is seeking a Clinical Research Coordinator to manage and support clinical trials across three fully onsite locations in Henderson and Las Vegas, NV. In this role, you will coordinate site initiation and sponsor-required training, dispense study medication, process labs, conduct informed consent processes, schedule participant appointments, and ensure accurate data collection and reporting. You will create source documentation, perform blood draws and ECGs with appropriate credentialing, identify and report adverse events, prepare and submit regulatory documents, and advise healthcare providers on protocol adherence. The position also focuses on quality assurance, performance improvement, participant recruitment and retention, and compliance with FDA, OHRP, and institutional regulations. You will support feasibility assessments for new trials, work with billing staff to ensure compliance, and attend required meetings. Flexibility in work schedule and adherence to mandatory training and conduct standards are essential.
Job Responsibility:
Coordinate and participate in site initiation and sponsor-required training for all protocols
Dispense study medication to research participants under the direction of the Principal Investigator (PI), and/or coordinate study drug administration with hospital/clinic Pharmacy staff
Process labs for clinical trials, including collecting, centrifuging, aliquoting, and shipping specimens in accordance with federal biologics shipping regulations
Conduct informed consent process with research participants
document informed consent discussion and obtain signatures per protocol, federal, state, and institutional requirements
Coordinate all study-required visits, procedures, tests, and activities to meet protocol requirements
schedule participant appointments with appropriate provider/facility
Perform timely and accurate collection and reporting of data in accordance with protocol, sponsor, and institutional requirements, applicable laws, and policies
Create source documentation forms/templates to ensure accurate collection of all study data
maintain research subject charts/binders to meet protocol requirements
With appropriate training/credentialing, perform blood draws, ECGs, and other testing (e.g., NIH Stroke Scale) as required by research protocols
Identify and report all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations, or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP, and institutional policy
Prepare, manage, and submit all required study/regulatory documents, applications, and forms, including but not limited to IRB application forms, informed consent documents, 1572 forms, Conflict of Interest forms, and other sponsor or institutional forms
Advise and instruct the PI and other healthcare providers on protocol-required tests and procedures to ensure protocol adherence, accurate data collection, and billing compliance
Develop and implement effective strategies for promoting, recruiting, and retaining research participants in long-term clinical trials
actively recruit, screen, and enroll participants
Attend investigator/coordinator meetings as required by study sponsors
Serve as liaison among participants, physician investigators, sponsors, IRBs, administration, patient care coordinators, and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions
Coordinate and participate in sponsor monitoring visits or internal/external audits
resolve queries and findings promptly
prepare responses or corrective action plans as needed
Implement and monitor clinical trials and research projects to ensure compliance with protocol, sponsor, FDA, OHRP, and institutional requirements
Support feasibility assessments for new trials, complete sponsor feasibility questionnaires, and provide recommendations for implementation at the site
Work with billing staff to ensure clinical trials are performed in accordance with institutional requirements
complete Research Encounter Forms for all participant visits
Meet all mandatory requirements of the position, including training, licensure/certification, employee health requirements, and adherence to the organization’s Code of Conduct
Flex work schedule as needed to accommodate participant visits, sponsor deadlines, or program needs
work hours may exceed 40 hours per week based on workload and deadlines
Attend local IRB and clinical department meetings as needed for presentation and review of new protocols
Obtain PI signatures on all required study documents
Requirements:
2+ years of Clinical Research Coordinator (CRC) experience required
Clinical-specific experience required
Lab processing experience required
Experience preparing and maintaining regulatory and IRB-related study documentation required
CRC certification required
Ability to coordinate and participate in site initiation and sponsor-required training
Experience dispensing study medication and coordinating drug administration with pharmacy staff
Ability to process labs for clinical trials and ship specimens per regulations
Experience conducting informed consent processes and documenting per protocol and regulatory requirements
Ability to coordinate study-required visits, procedures, tests, and activities
Accurate data collection and reporting in accordance with protocol and sponsor requirements
Ability to create source documentation and maintain research subject charts/binders
Experience identifying and reporting adverse events and protocol deviations
Ability to prepare, manage, and submit study/regulatory documents and forms
Effective participant recruitment, screening, and enrollment skills
Ability to serve as liaison between participants, investigators, sponsors, IRBs, and other stakeholders
Experience preparing for and participating in sponsor monitoring visits and audits
Knowledge of FDA, OHRP, and institutional regulations and requirements
Flexibility to work onsite at multiple locations and adjust schedule as needed
Ability to meet all mandatory training, licensure/certification, and conduct requirements
Nice to have:
neuro, cardio, or oncology background
Phlebotomy certification
What we offer:
competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs
401k plan that includes a company match and is fully vested after you become eligible
paid time off, sick time, and paid company holidays
Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching