The Department of Ophthalmology at Stanford University is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical and laboratory studies. The candidate is desired to have basic life research experience, in addition to experience and passion in the patient care setting. The candidate will be working closely under the direction of Principal Investigator, Dr. Vinit Mahajan, Associate Professor of Ophthalmology, and/or study coordinators/supervisor. The Coordinator will coordinate moderately complex aspects of one or more clinical studies. Additional experience in genetics counseling or genetics research a plus.

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.
• Train and assist in facilitating established translational research workflows
• Coordinate collection of study specimens and processing in the clinic and operating room
• Assist with departmental biorepository project and retinal dystrophy genotyping initiative
• Transport collected samples between Stanford facilities
• Work alongside clinic and OR teams
• Perform inventory and stock required study supplies
• Perform basic biochemical techniques in lab on research samples (isolate DNA, prep cell product for assays, etc.)
• Collaborate with other researchers and clinicians to interface the lab with the patient care setting
• Collect and manage patient and laboratory data for clinical research projects.  Create and manage research project databases, generate reports, develop flow sheets and other study related documents, and complete study documents/case report forms.
• Build and deliver presentations
• Perform quality control and auditing on data
• Interact with patients and families in the clinical care setting
• 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.

* - Other duties may also be assigned

DESIRED QUALIFICATIONS:

The desired candidate should have familiarity with Macintosh and PC devices, and is desirable that they have experience with software applications such as Outlook, Microsoft office, Pages, and Excel, and online databases. It is desired that the candidate has a combined 3-6 months’ experience working in a clinical setting with previous phlebotomy experience. Candidate should also be knowledgeable of medical and basic ophthalmological terminology, and previous clinical research experience with informed consents and IRBs. Ideal candidate will have laboratory experience with DNA isolation, tissue culture, and lab management.

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, http://adminguide.stanford.edu.

Additional Information

• Schedule: Full-time
• Employee Status: Regular
• Grade: F
• Department URL: http://ophthalmology.stanford.edu/