Clinical Research Coordinator Associate

Stanford University, Department of Anesthesiology, Pain & Perioperative Medicine, Division of Pain Medicine is seeking a 100% remote Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of a national research study.  The study, Patient Voice for Access and Analgesia in Long-Term Pain and Opioid Use (VALUE), is patient-centered and aims to: (1) learn about the perspective and experience of people who require prescription opioid treatment for chronic pain; and (2) learn about the problems people may have in accessing their medications. Results from our research may help future patients, families, and doctors make medical decisions about the best treatment for their chronic pain, and it may be used to inform future patient-centered policies.

The CRCA will coordinate moderately complex aspects of the study, including recruiting individuals across different states.  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 recruiting nationwide in the United States, 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 is 100% remote.  

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.
• 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 study retention and schedule follow-up call after each survey to verify medication data. 
• 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 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. Verify surveys are properly functioning in the electronic research database (CHOIR) and generate reports on recruitment, enrollment, and adverse events. 
• 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 expenses related recruitment strategies and participant compensation.
• Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. 
• Ensure essential documentation and recording of participants 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 may be required within study site locations.

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 .