Stanford University, Department of Anesthesiology, Pain & Perioperative Medicine, Division of Pain Medicine is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of two randomized controlled trials study. The primary study, Single Session Pain Catastrophizing Class: Efficacy & Mechanisms for Reducing Opioid Use Among Chronic Pain Patients, aims to determine the efficacy of a targeted single-session psychology class in reducing opioid use among patients with chronic pain. The information gained from this study has the potential to identify patients who achieve a meaningful reduction in opioid use and inform opioid reduction strategies.
The CRCA will coordinate moderately complex aspects of the clinical study (including different sites of recruitment) under the direction of the principal investigator. Patients with any type of chronic pain may enroll, except for patients with active addiction, or behavioral or safety concerns. The project focus on outpatient settings, where most U.S. patients receive prescribed opioids.
This position will potentially include travel to sites within the Bay area (study sites include Redwood City, Emeryville, San Jose, Oakland, Los Altos, and Santa Clara). Duties Include:
Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. Facilitate all matters related to patient recruitment - screening, enrolling and consenting. The coordinator may approach patients during their clinic visits, may send the patient information in advance, or encourage the patient to arrive early to learn about the study.
Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies. The coordinator will serve as the study contact for all potential participants and for all enrolled participants throughout the duration of their participation in the study.
Coordinate collection of study specimens and processing. Track class attendance for (for those assigned to either Pain Catastrophizing and Health Education).
Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms.
Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed.
Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
Participate in monitor visits and regulatory audits.
*Other duties may also be assigned Desired Qualifications:
Bachelor's degree strongly preferred.
Ability to work under deadlines with general guidance is essential.
Excellent organization skills and demonstrated ability to accurately complete detailed work.
Ability to learn and master computer programs, databases, and scientific applications.
Strong analytical skills and excellent judgment.
Education & Experience (Required):
Two year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.
Knowledge, Skills and Abilities (Required):
Strong interpersonal skills.
Proficiency with Microsoft Office.
Knowledge of medical terminology.
Certifications & Licenses:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
*Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
Occasional evening and weekend hours.
May travel to sites within the Bay area (study sites include Redwood City, Emeryville, San Jose, Oakland, Los Altos, and Santa Clara).
Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.
Location: School of Medicine, Stanford, California, United States Schedule: Classification Level:
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 9000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu. Stanford University is an ...equal opportunity employer and is committed to increasing the diversity of its faculty. It welcomes nominations of and applications from women, members of minority groups, protected veterans and individuals with disabilities, as well as from others who would bring additional dimensions to the university’s research, teaching and clinical missions.