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Clinical Study Project Manager - Stanford, CA, United States - Stanford University
Description
The Stanford University Department of Orthopaedic Surgery in the Division of Pediatric Orthopaedic Surgery is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of various clinical studies and data-driven projects related to spinal surgery and scoliosis outcomes.
This position coordinates moderately complex aspects of the clinical studies and works under close direction of the research manager and Principal Investigator.
The ideal candidate will serve as the primary point of contact for the study participants and be motivated to support a cohesive and mission driven team of faculty and staff that are advancing the field of Orthopaedic Surgery.
Excellent communication and relationship building skills;Strong attention to detail and commitment to uphold regulatory compliance; Drive to establish themselves as a leading contributor within the Department of Orthopaedic Surgery.
Serve as primary contact with research participants, sponsors, and regulatory agencies. 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.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.
* - Bachelor's Degree in biology, chemistry, public health or other health-related field.
~1-2 years working in clinical research.
~ Prior data entry and management experience.
Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.
General knowledge of medical terminology.
Attention to detail in data collection and excellent organizational skills.
General computer skills and ability to quickly learn and master computer programs such as REDCap, Microsoft Office.
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
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.Occasional evening and weekend hours.
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, .
54 per hour.
The Cardinal at Work website () provides detailed information on Stanford's extensive range of benefits and rewards offered to employees.
Applicants requiring a reasonable accommodation for any part of the application or hiring process should contact Stanford University Human Resources by submitting a contact form .
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.
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.
