The Division of Sleep Medicine in the Department of Psychiatry & Behavioral Sciences at Stanford University is seeking a fulltime position 100%FTE Clinical Research Coordinator Associate. The Clinical Research Coordinator Associate will work closely with the physicians and staff at the Stanford Sleep Medicine Center to ensure that patients are properly enrolled in the research study, receive complete information about their tests and procedures, have their data from their tests and outcome measures properly collected, and are provided access to their results. They will coordinate moderately complex aspects of one or more clinical studies and work under close direction of the Division Chief.
DESIRED QUALIFICATIONS:
BA/BS degree in a related science field
Prior experience with project management
Basic knowledge of medical terminology
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.
Ability to drive day or night, if applicable.
WORKING CONDITIONS:
Occasional evening and weekend hours.
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.
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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.