The Bronte-Stewart Lab is part of the Stanford Movement Disorders Center within the Department of Neurology and Neurological Sciences at Stanford University School of Medicine. We are seeking an experienced, full-time clinical research coordinator to join a dynamic and fun international group of post-doctoral fellows, graduate students and research scientists. The Clinical Research Coordinator Associate (CRCA) will perform duties related to the coordination of clinical studies. The CRCA will coordinate moderately complex aspects of one or more clinical studies and work under the general direction of the principal investigator, research team and/or study coordinator/supervisor.
The Clinical Research Coordinator Associate is responsible for the overall management and implementation of an assigned set of multiple research protocols assuring efficiency and regulatory compliance. The candidate will work as part of the lab research team and coordinate between lab members/PI and regulatory agencies. Responsibilities include preparation of initial study documents for IRB submission in compliance with all local, state and federal regulations; advise the IRB of amendment changes to the protocol and complete annual protocol renewals. Recruit, screen, assist in the informed consent process and enroll subjects in accordance with good clinical practice guidelines. Collect, record and maintain complete data files using good clinical practice in accordance to HIPAA regulations. The candidate may participate in data retrieval, reporting, and preparation of files and Case Report Forms for the various studies.
The ideal candidate will be highly organized and professional with experience in coordinating research studies. The candidate should have excellent attention to detail and strong adherence to deadlines. Candidate should be an independent, self-starter who is interested in facilitating the regulatory side of the lab's research.
Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out.
Coordinate initiation of research studies, working collaboratively with the research team, study sponsor, IRB, FDA, RMG, and industry collaborators
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
DESIRED QUALIFICATIONS:
Bachelor's degree with an educational background in medicine and/or science (e.g. biological sciences, social sciences, etc.)
Strong oral and written communication skills
Highly organized and excellent attention to detail
Proficiency using computers, software and web-based applications in a previous administrative setting
Minimum 2-year commitment
2+ years' experience as a clinical research coordinator Familiarity with statistical analysis software packages (e.g. SPSS, R, SigmaPlot)
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.
Job:
Location: School of Medicine, California, United States
Schedule:
Classification Level:
To be considered for this position please visit our web site and apply on line at the following link:stanfordcareers.stanford.edu
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
