Clinical Research Coordinator Associate

at  Stanford University

The Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine (PACCM) is comprised of a team of outstanding clinicians, scientists, and scholars dedicated to improving the lives of patients with serious lung disease. Our goal is to provide outstanding clinical and research training to the next generation of leaders in Pulmonary and Critical Care Medicine. We are committed to strong clinical investigations including the evaluation of new pharmacologic agents, which offer potentially promising therapeutic benefits, as well as outcome studies which characterize clinical parameters to effect positive changes in patient care.
PACCM is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies. Coordinate moderately complex aspects of one or more clinical studies. Work under close direction of the principal investigator and/or study coordinator/supervisor. Demonstrate capacity and willingness to learn about various aspects of clinical research (patient recruitment, coordination of study visits, preparation of regulatory documents and materials, participation in audits and monitoring visits, etc.).

DESIRED QUALIFICATIONS:

• At least one year of Clinical Research experience.
• Proficiency in use of electronic data capture systems.
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.

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.

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.

DUTIES INCLUDE:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up 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.

STANFORD UNIVERSITY PROVIDES PAY RANGES REPRESENTING ITS GOOD FAITH ESTIMATE OF WHAT THE UNIVERSITY REASONABLY EXPECTS TO PAY FOR A POSITION. THE PAY OFFERED TO A SELECTED CANDIDATE WILL BE DETERMINED BASED ON FACTORS SUCH AS (BUT NOT LIMITED TO) THE SCOPE AND RESPONSIBILITIES OF THE POSITION, THE QUALIFICATIONS OF THE SELECTED CANDIDATE, DEPARTMENTAL BUDGET AVAILABILITY, INTERNAL EQUITY, GEOGRAPHIC LOCATION AND EXTERNAL MARKET PAY FOR COMPARABLE JOBS.

At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.