Stanford University, Department of Anesthesiology, Pain & Perioperative Medicine, Division of Pain Medicine is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of a large multi-site clinical research study. The study, Comparative Effectiveness of Pain Cognitive Behavioral Therapy and Chronic Pain Self-Management within the Context of Opioid Reduction, is a patient-centered study that encourages patient interest and willingness to actively and collaboratively reduce opioid use and test two well-established behavioral intervention pain treatments. 

Coordinate moderately complex aspects of the clinical study, including multiple sites.  Work under the direction of the principal investigator and Clinical Research Manager. Patients with any type of chronic pain may enroll, except for patients with active addiction, or behavioral or safety concerns. Our project focuses on community outpatient settings, where most U.S. patients receive prescribed opioids. Our project is designed so that the results can be broadly applied to anywhere in the United States.

This position will include traveling to sites within the Bay Area (study sites include Redwood City, Emeryville, Oakland, Los Altos, and Santa Clara).

Core 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 send the patient information in advance, or encourage the patient to arrive early to view some brief videos 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 patients assigned to the behavioral treatment groups (for those assigned to either Cognitive Behavioral Therapy, pain-CBT, or Chronic Pain Self-Management, CPSMP). 
• Coordinate scheduling and launching of new treatment cohorts for pain-CBT and CPSMP, and ensuring that peer-leader and psychologists are confirmed and back-up systems in place.
• 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.  Ensure the local study procedures and operations are in compliance with IRB and HIPAA, including modifications and continuing review documents.
• Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. Coordinators will be responsible for ensuring an adequate number of study iPads are available to patients in the clinic lobby and that they are working to display the study recruitment videos and CHOIR is operational.  Arrange study patient focus groups and, with input from the Study Advisory Committee and all team members, determine if protocol changes are needed. Assist the Site Director in establishing a Site Patient Advisory Panel. The coordinator will maintain contact with the Site Patient Advisory Panel and engage them for advice on the study and how to enhance our systems to best meet the needs of local patients. 
• Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.  May need to work with clinic staff to track insurance, approvals, and billing status for patients assigned to pain-CBT.
• Interact with the principal investigator and clinical research manager 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.

Physical Requirements:

• 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.

Working Conditions: 

• Occasional evening and weekend hours.
• Travel to recruiting sites (participating clinics) throughout the Bay Area. 

Work Standards:

• 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.