The Stanford Prevention Research Center, within the Department of Medicine, 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 and work under close direction of the principal investigator and/or study coordinator/supervisor.

The Women’s Health Initiative (WHI) Study is a follow up study for a large multicenter clinical trial. Launched in 1993 WHI enrolled 161,808 women into one or more clinical trials followed by 40 clinics across the country. Currently 12,407 are being followed up by the Stanford Western Regional Center. The Osteoporotic Fractures in Men Study (MrOS) is an NIH funded study with six clinical sites which began in 2000. Originally 5994 older men were enrolled. Currently 377 participants are being followed at the Stanford site.

The purpose of this position is to follow up with our 12,407 Women’s Health Initiative Study participants and 377 MrOS participants to ensure the completion of yearly health forms (WHI) and questionnaires mailed three times per year (MrOS) and gather health information on medical events. Under the direction of the Regional Field Manager (WHI) and Project Director (MrOS) and following the study protocol, this Clinical Research Coordinator Professional will conduct phone interviews with elderly women and men to complete annual health forms, will resolve queries and errors on scanned forms, and will accurately enter form information into the database in a timely and efficient manner.

The candidate will also request medical documentation from medical providers, review and assemble medical cases for further review. In addition, the candidate will assist the Outcomes Coordinators as needed with the identification, investigation, documentation, and ultimately the adjudication of major clinical outcomes as they occur. In addition, the candidate will complete searches to locate participants who are lost to follow up or have undeliverable addresses. This involves searches, as well as mailings to participants and/or to participants designated contacts. This position requires daily contact with participants or their families and daily interaction with WHI staff.

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.
• 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.

*- The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.

DESIRED QUALIFICATIONS:

• General understanding of scientific theory and methods.
• Spanish speaking, a plus but not required.
• Familiarity or proficiency with Excel and Microsoft Word.
• Willingness to work with older adults.
• Ability to quickly learn.
• Ability to work under deadlines with general guidance.
• Excellent organizational skills and demonstrated ability to complete detailed work accurately.
• Effective oral and written communication skills.

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.

Why Stanford is for You:

Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:

• Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
• A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
• A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
• Discovery and fun. Stroll through historic sculptures, trails, and museums.
• Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.

*- Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.

Additional Information

• Schedule: Full-time
• Job Code: 4924
• Employee Status: Regular
• Grade: F
• Requisition ID: 88041