Clinical Research Coordinator Associate - 74748
Description The Division of Sleep Medicine within the Department of Psychiatry and Behavioral Sciences at Stanford University is seeking an 80% FTE Clinical Research Coordinator Associate. The Clinical Research Coordinator Associate will work closely with the physicians and staff at Stanford Primary Care and the Stanford Sleep Medicine Center to ensure that patients are properly enrolled in the project, 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. This individual will be involved in all aspects of patient care in the project and will be responsible for consenting patients, tracking the patients and their outcomes, and collecting and transferring samples and data in a secure and quality-assured manner. This individual will work closely with the Principal Investigator and research administrative staff to ensure the project is meeting goals.
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.
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.
* - Other duties may also be assigned
Qualifications EDUCATION & EXPERIENCE (REQUIRED):
Two year college degree and two years related work experience or a Bachelors 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.
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.
Position is needed to work between the hours of 2:00 PM - 10:00 PM and occasional weekend hours as needed.
Location: School of Medicine
Job Code: 4924