Overview
We are seeking a dynamic and highly organized Psychiatric Nurse Research Operations Manager to lead and coordinate research activities within psychiatric and mental health settings. This pivotal role involves overseeing clinical research operations, ensuring compliance with regulatory standards, and managing multidisciplinary teams to advance in-patient mental health research initiatives. The ideal candidate will bring a passion for improving patient outcomes through innovative research, combined with strong leadership skills and a comprehensive understanding of clinical trial processes in psychiatric care.
Duties
- Lead the planning, execution, and oversight of psychiatric in-patient care, ensuring adherence to study protocols and regulatory guidelines.
- Supervise research staff, including nurses, coordinators, and laboratory personnel, fostering a collaborative and compliant work environment.
- Review clinical documentation for accuracy, completeness, and compliance with Good Clinical Practice (GCP) and FDA regulations.
- Monitor patient safety by tracking vital signs, blood sampling procedures, and overall patient well-being during trials.
- Coordinate data collection, entry, and management using electronic medical record (EMR) systems and adhere to CDISC standards for data standardization.
- Ensure compliance with healthcare regulations such as HIPAA and clinical ethical guidelines throughout all research activities.
- Oversee clinical laboratory operations related to blood sampling, phlebotomy procedures, and analysis skills required for accurate specimen handling.
- Manage project timelines, budgets, and resources effectively while maintaining high standards of clinical quality assurance.
- Conduct regular training on GCP, ICH guidelines (International Conference on Harmonisation), FDA regulations, and healthcare compliance standards for all team members.
Qualifications
- Proven supervising experience in a clinical research or healthcare setting with a focus on in-patient psychiatric or mental health research.
- Strong knowledge of medical terminology, clinical research methods, and healthcare compliance regulations including HIPAA.
- Experience reviewing clinical documentation for accuracy and regulatory adherence.
- Familiarity with statistical software packages used in clinical data analysis.
- Demonstrated understanding of FDA regulations, ICH GCP guidelines, CDISC standards, and clinical ethical guidelines.
- Hands-on experience with EMR systems, blood sampling techniques such as phlebotomy, vital signs monitoring, and blood analysis procedures.
- Project management experience within healthcare or clinical trial environments; certification in project management is preferred.
- Certified in Good Clinical Practice (GCP) from an accredited issuer.
- Knowledge of clinical laboratory operations and data management practices essential for maintaining high-quality research standards.
- Excellent analysis skills combined with the ability to lead multidisciplinary teams effectively in a fast-paced research environment.
Join us to be at the forefront of mental health innovation, and welcome to Rivus!
Pay: From $95,000.00 per year
Work Location: In person
