Clinical Research Coordinator Associate

Stanford University is seeking a Clinical Research Coordinator Associate to perform duties related to the coordination of clinical studies. Coordinate moderately complex aspects of one or more clinical studies. Work under close direction of the principal investigator and/or study coordinator/supervisor.

Department, Division and Research Lab The overall mission of the Division of General Pediatrics in Stanford’s Department of Pediatrics is to improve the health and well-being of all children through cross-disciplinary advancements in patient care, medical education, advocacy, community engagement, and research. The coordinator will join Dr. Anisha Patel’s research lab “Partnerships for Research in Child Health”, whose work includes community-engaged research to improve child and adolescent nutrition and health. This position offers opportunities to collaborate with faculty from other institutions, research coordinators, staff, and students within the division, as well as community partners, school administrators, school nutrition professionals, and adolescent participants. The coordinator will gain hands-on experience in school-based research, engagement of youth and families, and the implementation and evaluation of nutrition interventions. To learn more about the lab and its work, visit researchinchildhealth.org.

School Meal Action This position will primarily support the School Meal Action study, but the CRC Associate should be able to work with other team members to assist in other studies, such as the Tap Trust study, which is described above.

School Meal Action is a high school student-led program designed to improve school nutrition and promote student health in California’s San Joaquin Valley. This study builds on the work of a community-academic partnership focused on improving access to healthy food in a largely rural region with high rates of diet-related disease.

School Meal Action will engage high school students in learning about school meal programs, use photography and discussion through a method called Photovoice to identify what is working and what needs improvements related to school nutrition, and collaborate with adult mentors and school and district leaders to advance solutions. The study will evaluate the program in a randomized trial involving 24 high schools serving students from low-income communities. Researchers will assess effects on student dietary quality, body mass index, blood pressure, and school meal participation, as well as students’ knowledge, attitudes, skills, and confidence. The study will also examine program implementation and sustainability to inform potential expansion to other schools.

Qualifications and Opportunities Interactions with high school students, school personnel, and community partners will be central to this role. The successful candidate will bring strong interpersonal, oral and written communication, and organizational skills; attention to detail; and the ability to manage multiple priorities. A flexible schedule and availability to travel to participating schools in California’s San Joaquin Valley will be important to support school-based activities and data collection. This position offers hands-on experience in community-engaged research, adolescent health, nutrition, and the implementation and evaluation of a school-based intervention

Duties include:

• Serve as primary contact with research participants, schools & personnel, study team, community collaborators, sponsors, and regulatory agencies. Coordinate studies from startup through close-out, including scheduling, communications, and study logistics.
• Determine eligibility of and gather consent/assent from study participants according to protocol. Assist in developing and implementing recruitment strategies.
• Support implementation of the School Meal Action program and comparison curriculum, including coordinating materials, training sessions, and school-based activities.
• Coordinate collection of data from schools and participantsfollowing appropriate training and study protocols: including student surveys, height and weight measurements, blood pressure measurements, and validated 24-hour dietary recalls; school meal participation data and assessments of school nutrition guidelines and practices; school observations, interviews, and focus groups with student participants and program implementers to assess program implementation, reach, and sustainability.
• Collect and manage data for clinical research projects. Develop and maintain study databases, tracking systems, data collection forms, and other study documents; review data for completeness and accuracy and resolve discrepancies.
• Prepare Institutional Review Board submissions, modifications, and renewals as required, and maintain regulatory documentation in accordance with institutional policies and applicable requirements.
• Protect participant privacy and confidentiality, maintain secure study records, and follow approved procedures for collecting and managing student and adult data and Photovoice materials.
• Communicate regularly with the principal investigator regarding study progress, recruitment, implementation challenges, participant safety, and adherence to study protocols.
• 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 participant 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 if required.
• Other duties may also be assigned

DESIRED QUALIFICATIONS:

• Master’s degree in public health or related field.
• Previous experience related to nutrition.
• History of work with youth and families. Prior work in school settings is a plus.
• Interest in working in a position for at least two (2) years.
• Experience with IRB protocols
• Prior work with REDCap or other data collection software
• Strong organizational skills
• Excellent English communication (written and verbal)
• Prior experience using Canva and PowerPoint
• Understanding statistics and familiarity with STATA or similar data analysis software
• Ability to drive and travel to sites
• Ability to travel to the San Joaquin Valley for up to 1-2 weeks quarterly
• Ability to work on site
• We are unable to sponsor work Visas.

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.
• Additional WORKING CONDITIONS: As this study takes place in the San Joaquin Valley, travel to Fresno and Bakersfield for 1-2 weeks periods is expected quarterly.

Core Duties:

• Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from start-up through closeout.
• 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.

Minimum Education and Experience 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:

• Strong interpersonal skills.
• Proficiency with Microsoft Office.
• Knowledge of medical terminology.

Certificates and Licenses Required Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.

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Drivers License Requirements

• Must possess and maintain a valid California non-commercial Class C Driver's License.
• Ability to drive day or night.
• When conducting university business, must comply with the California Vehicle Code and Stanford University driving requirements.