The Clinical Research Coordinator Associate is responsible for the overall management and implementation of an assigned set of multiple research protocols, ensuring efficiency and regulatory compliance. These studies will be conducted at the Stanford Hospital and Clinics. The coordinator will work as part of a clinical trials research team and report to various Principal Investigators conducting clinical research.
Responsibilities include:
• Preparation of initial study documents for IRB submission in compliance with all local, state, and federal regulations. • Advising the IRB of amendment changes to the protocol and completing annual protocol renewals. • Recruiting, screening, and enrolling subjects in accordance with good clinical practice guidelines. • Collecting, recording, and maintaining complete data files using good clinical practice in accordance with HIPAA regulations. • Participating in data retrieval, reporting, and preparation of files and Case Report Forms for various studies.
The successful candidate will interact with subjects by scheduling diagnostic and research evaluation visits, performing study-related assessments, including collection of blood samples and processing and shipment. The coordinator will also maintain drug accountability, adequate study supplies, and equipment.
Key duties include:
• Serving as the primary contact with research participants, sponsors, and regulatory agencies. • Coordinating studies from startup through close-out. • Determining eligibility of and gathering consent from study participants according to protocol. • Assisting in developing recruitment strategies. • Coordinating the collection of study specimens and processing. • Collecting and managing patient and laboratory data for clinical research projects. • Managing research project databases, developing flow sheets, and other study-related documents. • Ensuring compliance with research protocols and reviewing and auditing case report forms for completion and accuracy with source documents. • Preparing regulatory submissions and ensuring institutional Review Board renewals are completed. • Assembling study kits for study visits, monitoring scheduling of procedures and charges, and coordinating documents and attending monitoring meetings with sponsors. • Interacting with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. • Ensuring essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. • Participating in monitor visits and regulatory audits.
Education and Experience:
Two-year college degree and two years related work experience or a Bachelors degree in a related field or an equivalent combination of related education and relevant experience.
Knowledge, Skills, and Abilities:
• Strong interpersonal skills. • Proficiency with Microsoft Office. • Knowledge of medical terminology.
Certifications and 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. • Rarely kneel, crawl, climb ladders, grasp forcefully, sort, and file paperwork or parts. • Rarely lift, carry, push, or pull objects that weigh 40 pounds or more.
Working Conditions:
• Occasional evening and weekend hours.
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, and 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 Universitys Administrative Guide.
Pay Range:
The expected pay range for this position is $34.56 to $40.30 per hour.
Stanford University provides a comprehensive rewards package, including benefits and rewards, which can be discussed during the hiring process. The University is an equal employment opportunity and affirmative action employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
Additional Information:
Schedule: Full-time Job Code: 1013 Employee Status: Regular Grade: F Requisition ID: 108280 Work Arrangement: On Site