Reports to Senior Manager of Clinical Trials 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.
This position, knows and complies with all Kaiser Permanente quality, safety, and emergency policies and procedures. Demonstrates quality and effectiveness in work habits and clinical practice in every interaction with patients, colleagues, providers, and leadership. Ensures patient safety in the preparation and provisioning of care related to but not limited to medications, procedures, infection prevention, fall prevention, including consistent use of two patient identifiers and procedural time outs. Reports safety hazards, accidents and incidents, and unsafe working conditions promptly.
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.
Minimum five (5) years of clinical trials research involving human subjects.
Minimum three (3) years of supervisory responsibility.
Master's degree public health or related area.
Must be SoCRA or ACRP certified or eligible for SoCRA certification or ACRP certification (to be obtained shortly after hire).
Knowledge of IRB / research regulatory requirements.
Experience with quality assurance/compliance program monitoring and training.
Certification in Human Subjects Protection (post hire).
Certified Clinical Research Coordinator (preferred or will obtain post hire).
Knowledge of continuing education and staff development.
Additional Salary Information: Compensation package includes a 10% annual Incentive Bonus, annual merit increases and a very robust benefits package highlighted by company funded retirement and pension plans.
Internal Number: 954141
About Kaiser Permanente, Institute for Health Research
KAISER PERMANENTE - DIVISIONS, CENTERS, INSTITUTES FOR HEALTH RESEARCH
Operating one of the industry’s largest and most respected research programs, Kaiser Permanente employs nearly 1,800 research experts at 9 specialized centers across the country. With a research budget of $221 million and more than 2,500 studies and clinical trials underway at any given time, this is a place where you can have a profound impact on the future of health.
The Kaiser Permanente Colorado Institute for Health Research (IHR) is an integrated department that conducts, publishes, and disseminates epidemiologic, behavioral, health services, implementation and clinical research. The IHR also hosts a clinical trials program, and a robust community evaluation team. Research findings are translated into practice to improve the health of Kaiser Permanente members and the broader Colorado community, and to inform health care delivery and public policy nationally. The IHR has full-time and affiliate MD, PhD, and PharmD Investigators, supported by research staff including project managers, research specialists, research assistants, statisticians, analysts, programmers, as well as tumor registers, finance an...d administrative staff.
The organization has a specific focus on conducting research that can be translated into clinical practice, health promotion, and policies to influence the health of individuals and populations.
Established in 1992, the IHR is responsible for many landmark findings. Among the most notable are recent studies about overdose prevention, vaccine safety, food insecurity, genomics, and cancer screenings.