The Department of Pediatrics - Division of Endocrinology, successfully combines the worlds of integration, innovation, and clinical care to improve the diagnosis and treatment of endocrine disorders. Our mission is to innovate basic, translational, and clinical research in endocrinology and diabetes grounded in the principles of excellence and equity to advance scientific knowledge and improve the lives of all.
The Zaharieva Lab is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of physical activity/exercise clinical studies in type 1 diabetes. Dr. Dessi Zaharieva is the principal investigator of multiple cutting-edge studies focusing on strategies to manage blood glucose concentrations around exercise in youth and adults with type 1 diabetes. This dedicated CRCA will work closely with the PI and study supervisor as part of dynamic study team and will coordinate moderately complex aspects of multiple clinical studies at various stages.
This position will have the opportunity to engage and contribute to studies in unique and exciting ways such as website content development, comprehensive literature reviews, data management, clinical study coordination, patient engagement, qualitative and quantitative data collection, and more. Applicants should have working knowledge of the IRB application process and experience with common research platforms including, but not limited to: REDCap, Zotero, NVivo, Adobe Sign. Additionally, applicants should value high attention to detail, be innovative and collaborative, as well as demonstrate consistent initiative and follow through. Applicants should have strong written and verbal communication and be comfortable with or learning about technology (including insulin pumps and continuous glucose monitoring systems, physical activity trackers (watches), and smart devices).
Due to the nature of the studies, it is highly desirable for applicants to have a working knowledge and strong interest in physical activity/exercise and/or type 1 diabetes. This CRCA position is a full-time position and a commitment of at least two years is highly desirable. The position is hybrid, with an expectation of 2-3 of onsite work at the Stanford School of Medicine campus each week. However, the schedule may shift according to study timelines and goals, which may necessitate flexibility in work schedules (e.g. up to 4-5 days a week on site during clinical trial exercise portions, as needed).
Interested candidates, please apply with your resume and a cover letter. Please describe your background, prior clinical research experience, interest in exercise and/or type 1 diabetes, and future goals in your cover letter.
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 and implementing a variety of 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.
- Conduct study visits and semi-structured interviews, 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:
- Knowledge of type 1 diabetes
- Working knowledge of and strong interest in physical activity/exercise
- Experience with common research platforms including, but not limited to: REDCap, Zotero/Endnote or other referencing software, NVivo, Adobe Sign
- Knowledge of type 1 diabetes including diabetes devices such as continuous glucose monitoring (CGM) systems, insulin pumps, and automated insulin delivery (AID) systems
- Comfort with technology and devices such as physical activity trackers (watches); ability to independently troubleshoot challenges with devices and provide guidance to study participants
- Superior written communication skills to write and develop content for existing diabetes and exercise website
- Comfort in conducting literature searches and critically reviewing scholarly literature
- Experience with Zoom; including moderation of Zoom sessions and troubleshooting with study participants
- Experience with clinical trials, including recruitment of participants, implementing study procedures, and data collection
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.
- Superior attention to detail, time management skills, and ability to manage shifting priorities and deadlines
- Strong written and verbal communication
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:
Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious disease and infections.
