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Stanford University School of Medicine is seeking a CVICU Clinical Research Lead (50% FTE) to conduct clinical research and work independently on progressively more complex projects/assignments. This part-time position is within the Stanford Children’s Heart Center for Clinical and Translational Research and would work on inpatient research studies at the Lucile Packard Children’s Hospital Cardiovascular Intensive Care Unit (LPCH CVICU). The CVICU Clinical Research Lead will independently manage significant and key aspects of a large study or all aspects of one or more small research studies. We are seeking a candidate with excellent communication skills and desire to work with pediatric cardiac patients, their families, and clinical 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.
• 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

DESIRED QUALIFICATIONS:

• Excellent oral and written communication skills.
• Experience working in a clinical unit with clinical teams, patients and their families, and research study teams.
• Experience with managing clinical data entry and capture in a research setting.
• Medical background, knowledge, or experience in cardiovascular clinics, pediatrics, Intensive Care Units (ICU), or other similar medical units; and/or advanced degree in medical, health, science, or research related programs.
• Experience with review of EMR, including EPIC.
• Proficiency in using computers, software, and web-based applications.
• Experience training others on topics related to clinical research conduct and management or other related experiences.
• 2+ years of experience as a clinical research coordinator and additional trainings, competencies (e.g. GCP, etc.) obtained through continuing education, training coursework, webinars, conferences, clinical research organizations (e.g. SOCRA, ACRP, etc.) in any area of performing clinical research is strongly preferred.
• Proficiency with database applications.
• 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.

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.

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