Clinical Research Coordinator
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. To learn more about the Department please visit us at: https://ortho.stanford.edu/
The successful candidate will demonstrate:
- Excellent communication and relationship building skills;
- Strong attention to detail and commitment to uphold regulatory compliance; and
- 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 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.
* - Other duties may also be assigned
- Bachelor’s Degree in biology, chemistry, public health or other health-related field
- 1-2 years working in clinical research
- Ability to work fast and efficiently within time constraints
- Ability to work independently and comfortably with study participants
- Prior data entry and management experience
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor’s degree in a related field or an equivalent combination of related education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- General knowledge of medical terminology.
- Ability to work with human study participants as well as in a team
- Attention to detail in data collection and excellent organizational skills
- Ability to work under deadlines with general guidance
- Strong written and oral communication skills
- General computer skills and ability to quickly learn and master computer programs such as REDCap, Microsoft Office
- Ability to interpret, adapt, and apply guidelines and procedures
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
- 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.
Occasional evening and weekend hours.
- 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.
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