Clinical Research Coordinator Associate- HYBRID

Stanford University; Palo Alto (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

Stanford Radiology, part of Stanford University, is seeking a Clinical Research Coordinator Associate to coordinate clinical studies from start-up through closeout. You will recruit participants, obtain consent, schedule visits, and manage regulatory tasks under PI supervision.

Ideal candidates have 1–2 years in clinical research, strong organizational and communication skills, and familiarity with GCP/HIPAA. Proficiency in Microsoft Office and medical terminology is expected.

Qualifications

• Two-year college degree and two years related work experience or a bachelor’s degree in a related field.
• Experience coordinating clinical studies, participant recruitment, consent, and study visits.
• Familiar with GCP, HIPAA, and applicable clinical research regulations.
• Strong organizational, communication, and interpersonal skills.
• Proficiency with Microsoft Office; knowledge of medical terminology.

Responsibilities

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
• 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/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.
• 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.

Skills

Clinical research experience (1–2 yrs)

Organizational skills

Communication skills

Interpersonal skills

GCP knowledge

HIPAA knowledge

Microsoft Office

Education

Two-year college degree or bachelor’s degree in a related field

Tools

Microsoft Office

Job description

Stanford Radiology is committed to providing exceptional patient care by leveraging technology, innovation, and compassion. We also aim to educate and train the next generation of leaders in patient care and research. Our research and development team is working on advanced technologies, including molecular imaging, in vitro diagnostics, image-guided therapeutics, and informatics to improve precision health. We strive to foster a culture of diversity, inclusion, transparency, and integrity.

We are currently looking for a Clinical Research Coordinator Associate (CRCA) to assist with the coordination of clinical research studies. As a Clinical Research Coordinator Associate, you will coordinate various aspects of clinical studies, including participant recruitment and consent, study visits and procedures, regulatory activities, data collection and management, and study documentation. You will work under the direction of the principal investigator and/or clinical research supervisor and may independently coordinate assigned study activities within established protocols and procedures.

At Radiology, we are dedicated to recruiting team members who are enthusiastic about their work, adaptable, collaborative, and enjoy achieving outcomes. We prioritize providing our staff with the tools and support necessary to perform their jobs effectively, develop new skills, and advance within the organization. We also value a healthy work-life balance.

DESIRED QUALIFICATIONS:

• 1–2 years of experience in clinical research or a comparable research role.
• Strong organizational, communication, and interpersonal skills, with a demonstrated ability to manage multiple priorities and work effectively within a multidisciplinary team.
• Familiarity with Good Clinical Practice (GCP), HIPAA, and applicable clinical research regulations.

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, http://adminguide.stanford.edu.

Responsibilities

Core Duties:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
• 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/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.
• 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.

Minimum Education and Experience

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:

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

Certificates and Licenses Required

Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.