Clinical Research Coordinator Associate

Stanford University School of Medicine; Palo Alto (CA); On-site; USD 75,000 - 110,000; Full time

Job summary

Stanford University School of Medicine seeks a Clinical Research Coordinator Associate to oversee clinical studies within the Joint division of Orthopaedic Surgery. You will coordinate from start-up through closeout, determine eligibility, and manage data and regulatory submissions in a supportive multidisciplinary team.

Responsibilities include assembling study kits, monitoring visits, and ensuring patient safety and protocol compliance, while collaborating with physicians, scientists,

Qualifications

• Two-year college degree with two years related work experience or a bachelor’s degree in a related field.
• Strong interpersonal skills and ability to communicate clearly with participants and team members.
• Proficiency with Microsoft Office and knowledge of medical terminology; certification preferred.

Responsibilities

• Serve as primary contact with research participants, sponsors, and regulatory agencies; coordinate studies from start-up through closeout.
• Determine eligibility and obtain consent from study participants; assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing; manage patient and laboratory data for trials.
• Maintain study databases, flow sheets, and case report forms; ensure regulatory submissions and IRB renewals.
• Assemble study kits, monitor visits and scheduling; liaise with sponsors as primary contact.
• Monitor expenditures and study budgets; resolve billing issues with finance staff.
• Interact with the principal investigator to ensure patient safety and proper study conduct.

Skills

Interpersonal skills

Knowledge of medical terminology

Education

Two-year college degree

Bachelor's degree in related field

Tools

Microsoft Office

Job description

Job Description

The Department of Orthopaedic Surgery boasts a prominent national and international presence in orthopaedic research, representing a wide range of subspecialties within the field. This research encompasses treatments for musculoskeletal issues in patients spanning from infants to older individuals. The overarching goal of the Orthopaedic Research Program is to cultivate foundational knowledge that propels the advancement of musculoskeletal injury and disease treatments.

To further this mission, the department is seeking a dedicated Clinical Research Coordinator Associate (CRCA) to oversee clinical studies within the Joint division. The CRCA will operate within a dynamic and supportive environment, guided by a supervisor. This role offers the opportunity to collaborate closely with fellow coordinators, research assistants, physicians, scientists, biostatisticians, residents, and medical assistants who are at the forefront of transformative spinal care research. The CRCA must have strong communication and documentation skills and must be able to juggle competing project priorities and deadlines.

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

• 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.

Drivers License Requirements

• Must possess and maintain a valid California non-commercial Class C Driver's License.
• Ability to drive day or night.
• When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.