Lead CRC in Rheumatology Clinical Trials (5 yr exp) Wellnet Research Solutions Margate, FL Job Details Full-time $52,000 - $72,800 a year 1 hour ago Benefits Paid time off Qualifications Statistical software Statistics Spanish Clinical research Electronic health records (EHR) management Research ethical considerations Phlebotomy Biostatistics HIPAA Rheumatology English Clinical research protocol review Clinical laboratory experience ICH guidelines Blood sample handling Team management Attention to detail Project management experience in healthcare Managing clinical research teams Medical record abstraction Health information regulatory compliance Health information management IATA Certification Research and development project management Clinical data analysis Medical terminology FDA regulations Data analysis software Full Job Description Job Summary Wellnet Research Solutions is currently seeking a qualified Lead Clinical Research Coordinator with a minimum of five years of experience in rheumatology clinical trials as well as bilingual proficiency in English and Spanish. The Lead Clinical Research Coordinator (LCRC) works under the direction of the Principal Investigator (PI). While the PI is primarily responsible for the overall design, conduct, and management of the clinical trial, the LCRC supports, facilitates, and coordinates the daily clinical trial activities and plays a critical role in the study's execution. The LCRC collaborates with the PI, department, sponsor, and institution to ensure compliance and provide guidance on financial, personnel, and other related aspects of the clinical study. The Lead Clinical Research Coordinator reports directly to the Principal Investigator, with additional responsibilities to the department head, division administrator, or program administrator.

Important:

Please refrain from submitting your resume if you do not speak English and Spanish fluently. We do not accept applicants who are willing to relocate. It is mandatory that the candidate is not located more than 14 miles from the workplace. Duties Lead and supervise a team of CRCs and research staff to ensure seamless trial operations, including patient recruitment, screening, and follow-up procedures. Oversee all aspects of clinical trial documentation review, ensuring accuracy, completeness, and compliance with FDA regulations, ICH GCP guidelines, and healthcare privacy laws such as HIPAA. Monitor patient safety and progress throughout the study duration by reviewing medical records, lab results, and blood sampling data in accordance with clinical ethical guidelines. Manage data collection processes using electronic medical record (EMR) systems and ensure data integrity through rigorous quality assurance standards aligned with CDISC standards. Coordinate with clinical laboratories for sample processing and analysis, maintaining strict adherence to clinical laboratory experience requirements. Review protocol adherence, regulatory submissions, and audit readiness to ensure compliance with FDA regulations and clinical research compliance standards. Utilize statistical software for data analysis and reporting to support study milestones and regulatory submissions. Facilitate training sessions on Good Clinical Practice (GCP), ICH guidelines, and healthcare compliance for research staff to promote a culture of excellence in clinical research methods. Collaborate closely with project managers to develop timelines, budgets, and resource allocations for multiple ongoing studies within the rheumatology portfolio. Ensure all project documentation is maintained accurately in accordance with clinical quality assurance standards and project management best practices. Qualifications Minimum of five years' experience as a Clinical Research Coordinator or similar role within rheumatology or related therapeutic areas. Proven supervising experience leading multidisciplinary teams in a research setting. Strong knowledge of medical terminology, clinical research methods, and healthcare compliance regulations including FDA regulations, HIPAA, ICH GCP guidelines, and clinical ethical standards. Demonstrated expertise in data management systems, EMR platforms, statistical software, and CDISC standards for data collection and analysis. Experience reviewing complex documentation such as protocols, informed consent forms, case report forms (CRFs), and regulatory documents. Familiarity with blood sampling procedures and laboratory processes relevant to rheumatology studies. Project management skills with the ability to coordinate multiple trials simultaneously while maintaining attention to detail. Certification in ICH Good Clinical Practice (GCP) from a recognized issuer is required; additional certifications such as a CA certification are advantageous. Excellent communication skills combined with a proactive approach to problem-solving within a fast-paced research environment. Join us in advancing innovative rheumatology treatments through meticulous research management! We are committed to fostering an inclusive environment where your expertise can thrive while making meaningful contributions to patient health worldwide.

Pay:

$52,000.00 - $72,800.00 per year

Benefits:

Paid time off

Experience:

Clinical research: 5 years (Required)

Phlebotomy:

1 year (Required)

Language:

English (Required) Spanish (Required)

License/Certification:

GCP (Required) IATA Certification (Required)

Work Location:

In person