Clinical Research Assistant – Mind Body Interventions for Chronic Pain & PTSD

PAVIR•Stanford, CA

2d•Onsite

About The Position

Palo Alto Veterans Institute for Research (PAVIR) is seeking a full-time Clinical Research Assistant to support the Bayley lab at the Palo Alto VA. This lab focuses on using mind-body interventions, such as yoga and meditation, for rehabilitation treatments for chronic pain and posttraumatic stress disorder (PTSD). The Clinical Research Assistant will independently coordinate day-to-day clinical research activities, including participant recruitment and enrollment, informed consent, regulatory compliance, data management, study coordination, and communication with sponsors and regulatory agencies. The incumbent will serve as a primary point of contact for assigned studies and exercise independent judgment in coordinating study operations.

Requirements

Bachelor's degree or equivalent experience required
2 years of experience in healthcare system, handling sensitive health data, interacting with patients and assisting with administrative processes
Proficiency with Microsoft Word and Excel
Strong organizational skills and attention to detail
Effective communication skills, both oral and written
Good interpersonal skills in order to interact with study subjects
Basic math skills
Ability to read and understand the study protocol
Ability to comply with technical guidelines
Good time-management and prioritization skills
Ability to complete directed tasks independently
Assertiveness and creativity in the identification and resolution of barriers to progress

Nice To Haves

Master's degree in Psychology, Cognitive Science, Neuroscience, Anthropology, Public Health, Medicine or in a related field
2+ years of related experience, including subject recruitment, interacting with patients involved in research and/or therapeutic setting
Knowledge of standard concepts, practices, and procedures within the research field gained through education or experience
Ability to understand VA regulations and procedures regarding research
Strong understanding of GCP, FDA, IRB, HIPAA, and VA research regulations is strongly desired
Ability to independently manage multiple clinical research studies simultaneously
Previous experience in follow-up data collection
Knowledge and interest in complementary and integrative health, especially yoga desired
Knowledge of pain treatment or therapies highly desired

Responsibilities

Identify, screen, recruit, and enroll study subjects
Explain the study procedures to subjects
Obtain informed consent
Work with subjects to complete enrollment questionnaire
Answer any study-related questions from the study subjects
Schedule subject visits and collaborate with clinic staff as needed
Schedule follow-up tests/visits as needed
Report adverse events in a timely manner
Maintain subject record data and binders per sponsor direction
Monitor of regulatory aspects of the study
Collect, enter, and maintain data in study databases
Develop and refine data collection and data management procedures including conducting data analysis
Manage the database for internal and external audits and prepare summary reports
Prepare and submit IRB applications, amendments, continuing reviews, and reportable events, coordinating responses to regulatory requests independently
Review protocols for compliance with accepted research guidelines and ensure compliance with protocol guidelines and requirements of regulatory agencies and HIPAA regulations
Educate staff members on study design and timelines
Review documents and monitor the study protocol for continuous quality improvement
Develop and implement participant recruitment and outreach strategies to support enrollment goals
Other research related duties as needed
Educate and communicate with patients, families, referring physicians, local IRB, study sponsors, and the FDA
Determine guidelines for the collection of clinical data or administration of clinical studies
Implement initial patient recruitment strategy while ensuring protocol and prepare associated materials for IRB submission
Coordinate and implement procedures for data collection from patient charts, medical records, interviews, questionnaires, diagnostics tests, and other sources
Other duties as assigned