Clinical Trials Research Manager
2 weeks ago
Master's Minimum five (5) years of clinical trials research involving human subjects. Minimum five (5) years of supervisory responsibility. Minimum five (5) years of Ambulatory Nursing.
nice-to-have skills
Nurse Practitioner or Clinical Nurse Specialist. Certification in Human Subjects Protection (post hire). Certification in Biohazard Materials Transport (post hire
Job Summary:
Reports to Research Manager with responsibility for managing, directing, coordinating, leading and facilitating multiple clinical research trials, sites, and multi-disciplinary clinical research staff in testing and evaluation of investigational drugs and vaccines and clinical research studies involving specimen collection from human participants. Works directly with sponsors and investigators. Develops and maintains good clinical practice standards, budgets and staff development programs. Ensures compliance with organizational SOPs and government regulations for the conduct of research with human subjects.
Essential Responsibilities:
- Collaborates with principal investigators, study sponsors, trial monitors and the KPGA IRB in establishing, implementing and conducting clinical research trials. Manages the operations of clinical research units at multiple locations.
- Supervises clinical research staff, assesses their needs, and identifies educational opportunities. Recruits and hires new clinical research staff. Develops training materials, monitors adherence to KP education and training requirements, and takes responsibility for training new hires.
- Performs as point person for decision-making and problem-solving day to day operation of projects, including the resolution of technical problems and questions of research staff, external monitors etc.
- Manages the annual performance evaluation process for the clinical research staff. In conjunction with HR and management, coaches and counsels staff who are non-compliant with applicable KP policies, procedures and standards.
- Implements and oversees a compliance/quality assurance monitoring program for clinical trials. Collaborates in the management of research data collection involving human participants. Implements quality assurance programs and develops strategies that improve the quality of research conducted and patient care. Recommends corrections, remediation and corrective/preventive action plans based on trending and reporting of monitoring or audit findings.
- Proactively monitors trial budgets for appropriate use of human and material resources and how to effectively manage resources within study budgets.
- Assists in ensuring the delivery of high quality care and service that meets defined KPHP and KFRI standards and consistent compliance with the Nursing Practice Act, Guidelines for Good Clinical Practices, Federal, state and local regulations for the conduct of research.
Basic Qualifications:
Experience
- Minimum five (5) years of clinical trials research involving human subjects.
- Minimum five (5) years of supervisory responsibility.
- Minimum five (5) years of Ambulatory Nursing.
- Prior experience as a Clinical Research Coordinator for clinical trial(s).
- Masters degree in nursing.
- Registered Professional Nurse License (Georgia)
- Knowledge of IRB / research regulatory requirements.
- Nurse Practitioner or Clinical Nurse Specialist.
- Certification in Human Subjects Protection (post hire).
- Certification in Biohazard Materials Transport (post hire).
- Certified Clinical Research Coordinator (preferred or will obtain post hire).
- Experience with quality assurance/compliance program monitoring and training.
- Knowledge of continuing education and staff development.
Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.
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