Clinical Research Coordinator Associate (2 Vacancies) (On-Site)
Inside Higher Ed, Palo Alto, CA, United States
The Clinical Research Coordinator Associate is responsible for the overall management and implementation of an assigned set of multiple research protocols, assuring efficiency and regulatory compliance. The studies are conducted at Stanford Hospital and Clinics. The coordinator works as part of a clinical trials research team and reports to various Principal Investigators conducting clinical research. Responsibilities include preparation of initial study documents for IRB submission in compliance with all regulations; advising the IRB of amendment changes to the protocol and completing annual protocol renewals; recruiting, screening, assisting in the informed consent process and enrolling subjects in accordance with good clinical practice guidelines; collecting, recording and maintaining complete data files using good clinical practice in accordance to HIPAA regulations; participating in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies; interacting with subjects by scheduling diagnostic and research evaluation visits, performing study‑related assessments including collection, processing and shipment of blood samples; maintaining drug accountability, adequate study supplies and equipment; overseeing subject compliance to the study protocol; obtaining information from study subjects regarding any changes in their medications or adverse events and promptly reporting findings to physicians; reporting all serious adverse events promptly to investigators, sponsors and the IRB; and protecting the rights, safety and well-being of human subjects involved in the clinical trials.
Duties include
Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close‑out.
Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
Coordinate collection of study specimens and processing.
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 and case report forms.
Ensure compliance with research protocols, review and audit case report forms for completion and accuracy with source documents, and prepare regulatory submissions. Ensure institutional Review Board renewals are completed.
Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
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.
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.
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.
Pay Range
The expected pay range for this position is $34.56 to $40.30 per hour.
Equal Employment Opportunity Statement
Stanford is an equal employment opportunity and affirmative action employer. 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
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Duties include
Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close‑out.
Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies.
Coordinate collection of study specimens and processing.
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 and case report forms.
Ensure compliance with research protocols, review and audit case report forms for completion and accuracy with source documents, and prepare regulatory submissions. Ensure institutional Review Board renewals are completed.
Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact.
Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff.
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.
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.
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.
Pay Range
The expected pay range for this position is $34.56 to $40.30 per hour.
Equal Employment Opportunity Statement
Stanford is an equal employment opportunity and affirmative action employer. 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
#J-18808-Ljbffr