This position is located in Denver, Colorado and will include travel to sites within the Greater Denver Area (study sites include Aurora, CO). Please apply at for the Clinical Research Coordinator Associate position, job requisition 85516, at http://m.rfer.us/STANFORD2sYAWy.
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 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.
The CRCA will 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. Additional information is located at the following website: https://www.pcori.org/research-results/2017/comparative-effectiveness-pain-cognitive-behavioral-therapy-and-chronic-pain.
In this role, you will:
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-leaders and psychologists are confirmed and back-up systems in place.
Coordinate scheduling and launching of new treatment cohorts for pain-CBT and CPSMP, and ensuring that peer-leaders and psychologists are confirmed and back-up systems in
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. Work with clinic staff to track insurance, approvals, and billing status for patients assigned to pain-CBT.
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
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.
To be successful in this role, you will bring:
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.
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.
Strong interpersonal skills.
Proficiency with Microsoft Office.
Knowledge of medical terminology.
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.
Internal Number: 85516
About Stanford University
The Department of Anesthesiology, Perioperative & Pain Medicine is one of the largest departments in the Stanford University School of Medicine, with 180 faculty, of which approximately 30 have significant research interests. The department was 4th ranked in NIH funded anesthesiology departments in the country in 2015 we project an increase in funding this year. We have six different divisions offering opportunities for various levels of employment in research professional careers.