Senior Research Interventionist (KPWHRI))
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- Performs clinical evaluation, intervention and measurements requiring professional clinical knowledge, education and training. Uses clinical knowledge and skills to make decisions around patient safety and study participation issues. Evaluates responses of participants and makes independent judgments regarding the conduct of clinical interventions. Performs advanced medical record review as needed, and monitors quality of clinical measures across studies.
- In collaboration with Principal Investigator and Project Manager, contributes specialized clinical knowledge to the design and execution of clinical research studies. Participates in the planning phase of new studies, including maximizing the feasibility of the proposed studies, using knowledge of the specific study population and potential clinical settings. At the direction of the Principal Investigator, insures that clinical studies are implemented and conducted in accordance with IRB approvals, FDA regulations and GCP/ICH guidance. Designs study instruments, case report forms, and standard operating procedures to ensure data quality, optimal human subjects protections, and regulatory compliance. Represents the research study team on behalf of the Principal Investigator to external collaborators, study monitors, and KFHPW clinical sites. Ensures a seamless interface of clinical research studies with the provision of clinical care.
- Provides direct or functional supervision of clinical research staff to ensure proper execution of study protocols. May include the management and supervision of staff including the recruitment and selection of staff, the development and evaluation of staff and when necessary the discipline and termination of staff. Provides training to, and oversees clinical activities of clinical research staff members, or other relevant study staff within programmatic area of research. Coordinates clinical activities across multiple and/or complex research studies.
- Serves as a critical resource to managers and investigators in the Institute for matters relating to clinical practices, and the implementation of policies and procedures in clinical research studies.
- Minimum five (5) years of experience with clinical activities required by the research projects.
- Bachelors degree as determined by the needs of the research projects as follows: Registered Nurse, Nurse Practitioner, Certified Mental Health Therapist/Specialist, MSW, Pharmacist, Physical Therapist, Certified Health Education Specialist, Clinical Psychologist, or Acupuncturist.
- Experience with protocol development and clinical monitoring procedures required.
- Knowledge of research data collection requirements and specialized clinical intervention/measurement/assessment skills as required by the projects.
- A thorough understanding of regulatory policies governing industry practices, HIPAA requirements for clinical research, and knowledgeable about patient safety and quality control requirements.
- Excellent written and verbal communication skills, organizational skills and interpersonal skills.
- Ability to work independently and to provide leadership in a team setting.
- Two (2) years of clinical trials research or clinical data collection experience.
- Seven (7) years of experience as research interventionist or intermediate to high-level clinical research professional.
- Supervisory, staff training, and leadership experience.
- Demonstrated experience in working through the development, implementation, and closeout phases of research projects.
- Masters degree or PhD in health-related field AND certifications, licenses, or degrees as determined by the needs of the research projects as follows: Registered Nurse, Nurse Practitioner, Certified Mental Health Therapist/Specialist, MSW, Pharmacist, Physical Therapist, Certified Health Education Specialist, Clinical Psychologist, or Acupuncturist.
External hires must pass a background check/drug screen. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with federal and state laws, as well as applicable local ordinances, including but not limited to the San Francisco and Los Angeles Fair Chance Ordinances.