Quality and Compliance Associate
SCCR seeks a Quality & Compliance Associate (CRCA) to coordinate implementation of project-specific quality management plans, monitoring, and audit plans. This position will be responsible for supporting multiple studies by ensuring adequate study start up, regulatory submissions and training for the study. This position will collaborate with project team members, sponsors and PIs to meet study objectives.
The Stanford Center for Clinical Research (SCCR) is an Academic Research Organization within the Stanford Department of Medicine. The mission of SCCR is to conduct and promote high-impact, innovative clinical research to improve human health. SCCR leverages the physical and intellectual resources of Stanford University and its affiliated teaching hospitals and research centers to achieve this mission.
The CRCA will report to SCCR’s Quality & Compliance Manager and work across a variety of therapeutic areas. This position will assist in the quality management of the entire study, and will ensure adherence to regulatory requirements.
- Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements.
- 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.
- Manage research project databases in conjunction with the study data managers, develop site flow sheets and other study related documents, and follow up with project partners.
- Track tasks and deliverables and invoice components of the study budget.
- Participate in monitor visits and regulatory audits.
- Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct.
- 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.
- Coordinate studies from startup through close-out by assisting with study startup activities and performing study management activities throughout the study period and closeout.
* - Other duties may also be assigned
- Demonstrated superb communication skills in speaking and writing
- Project management experience
- Clinical research experience
- Clinical Research Associate or other clinical research monitoring experience preferred
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.
- 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.