Stanford University’s Departments of Neurosurgery is seeking a Clinical Research Coordinator Associate (CRCA) to perform duties related to the coordination of the department’s clinical research studies and biobanking program, . Studies may include gene therapies, drug/ device trials, longitudinal natural history studies, and other PI-initiated projects dealing with pediatric neurosurgery treatments. The CRCA primary responsibilities will include: to recruit, screen and enroll subjects; Specimen collection, processing, storage and shipment; and assist with regulatory and financial requirements of the trial(s). We are seeking candidates with excellent written and verbal communication skills and able to follow through with specifically assigned deliverables. Some previous wet lab experience would be beneficial. There are opportunities for long term growth within the team, or the position can be a launching pad for a career in the biomedical sciences. This CRCA position is a full-time position, and a commitment of at least two years is preferred. CRCAs are expected to be available on site for up to 5 days a week. This position may require occasional evening and weekend hours.

Interested candidates, please apply with your resume and a cover letter. Please describe your background, interests, and future goals in the cover letter.

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.

Qualifications

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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.