Clinical Research Coordinator Associate

Stanford University School of Medicine; Redwood City (CA); Hybrid; USD 68,000 - 110,000; Full time

Job summary

Stanford University School of Medicine's Dermatology department seeks an experienced Clinical Research Coordinator Associate to coordinate moderately complex clinical studies under the PI and clinical research manager. In-person attendance is required between the Redwood City and Palo Alto sites.

The role involves determining eligibility, consent, specimen collection, data management, regulatory submissions, budgeting, and coordinating monitoring visits with sponsors.

Qualifications

• Bachelor’s degree with background in medicine or scientific field.
• 3 years clinical research experience preferred.
• Experience with HIPAA, FDA, IRB, and GCP.

Responsibilities

• Serve as primary contact with participants, sponsors and regulatory agencies; coordinate studies from start-up through closeout.
• Determine eligibility and obtain consent; assist in developing recruitment strategies.
• Coordinate collection of study specimens and processing.
• Collect and manage patient and laboratory data; manage study databases and study documents.
• Ensure compliance with study protocols; prepare regulatory submissions and IRB renewals.
• Assemble study kits, monitor scheduling and attend monitoring meetings with sponsors.
• Monitor expenditures and adhere to study budgets; resolve billing issues with finance/management staff.
• Interact with the principal investigator to ensure patient safety and study conduct.
• Document patient and research data per requirements; participate in monitor visits and audits.

Skills

Regulatory compliance

Clinical research coordination

Strong communication

Project management

Independent work

Team collaboration

Detail oriented

Spanish (language)

Education

Bachelor's degree in medicine/science

Two-year college degree + experience

Job description

Job Description

Stanford University’s Department of Dermatology is seeking an experienced Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of clinical studies. The CRCA will coordinate moderately complex aspects of one or more clinical studies and work under the close direction of the principal investigator and the clinical research manager. The CRCA will support federal and non-federal clinical research studies, including dermatological and investigative work in support of clinical trials, clinical research, or biomedical research focusing on “bench to bedside” treatment. This position requires in-person attendance between the Redwood City and Palo Alto sites.

Desired Qualifications

• A Bachelor’s degree with an educational background in medicine and/or scientific field (biological sciences, social sciences, etc.)
• Three years of clinical research experience preferred.
• Clinical research project management experience.
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
• Proven ability to work independently and take ownership of a project.
• Proven ability to work collaboratively and cooperatively in a team environment.
• Ability to work effectively in a fast-paced environment with multiple projects and timelines.
• Strong oral and written communication skills.
• Detail-oriented with excellent organizational skills.
• Proficiency in using computers, software, and web-based applications in a previous administrative setting.
• Fluency in Spanish is a plus.

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. Infrequently, the CRCA may be required to work over the weekends in order to meet the clinical trial deadlines and/ or work on any other duties assigned.
• This role is hybrid, though the coordinator should expect to be in person at the RWC campus three to four days per week to support the studies.

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.

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.