Clinical Research Coordinator Associate
Company: Stanford Medicine
Posted on: November 22, 2021
This position is located in Denver, Colorado and will include
travel to sites within the Greater Denver Area (study sites include
Aurora, CO ).
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:
- 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
- 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
- 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 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
- Participate in monitor visits and regulatory audits.
* - Other duties may also be assigned
- Bachelor's degree stronly preferred.
- Ability to work under deadlines with general guidance is
- Excellent organization skills and demonstrated ability to
accurately complete detailed work.
- Ability to learn and master computer programs, databases, and
- 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
- 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.
- Travel may be required within study site locations.
- Interpersonal Skills: Demonstrates the ability to work well
with Stanford colleagues and clients and with external
- 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
- 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 .
- Schedule: Full-time
- Job Code: 4924
- Employee Status: Regular
- Pay Grade: F
- Requisition ID: 89405 As an organization that receives federal
funding, Stanford University has a COVID-19 vaccination requirement
that will apply to all university employees, including those
working remotely in the United States and applicable
subcontractors. To learn more about COVID policies and guidelines
for Stanford University Staff, please visit
Keywords: Stanford Medicine, Oakland , Clinical Research Coordinator Associate, Healthcare , Oakland, California
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