Clinical Research Associate
4 weeks ago
Urology America, MSO is seeking an experienced Research Coordinator to join our team. This is an exciting opportunity to build and lead a growing research department, working closely with a highly motivated group of urologists.
Key Responsibilities:
- Develop and implement research protocols, ensuring compliance with federal and state regulations.
- Recruit and manage studies, including budget evaluation and negotiation.
- Maintain certifications in FDA, GCP, ICH, and other relevant regulations.
- Obtain and maintain patient consent, ensuring the highest ethical standards.
- Lead a team of research staff, providing training, delegation of responsibilities, and management.
- Work directly with patients to screen, consent, and complete necessary exams.
- Communicate with patients and their families, providing support and education.
- Manage EMR and data management systems, completing EDC, eCRFs, and maintaining records.
- Stay up-to-date with relevant software and programs, including trial design and statistical methods.
- Triage, record, and report adverse events, as well as protocol deviations.
- Collaborate with IRB, study sponsors, PIs, and Sub-Is, attending necessary meetings and calls.
- Develop and maintain department SOPs, NDAs, CVs, certifications, and other essential documents.
- Evaluate and maintain necessary equipment, ensuring HIPAA compliance.
- Manage study budgets, monitoring invoicing, billing, and payments.
- Participate in site visits, SIVs, monitoring, and close-out steps.
Requirements:
- Minimum 5 years of experience in conducting clinical trials.
- Urology-based clinical experience preferred.
- Venipuncture experience preferred.
- Certification via ACRP or equivalent preferred.
- Proficiency in computer software, including Microsoft Office, EMR, and Practice Management systems.
- Effective time management and prioritization skills.
- Excellent communication and interpersonal skills.
Urology America, MSO offers a competitive benefits package, including medical, dental, and vision insurance, 401(k) with employer contributions, and paid time off.
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