Clinical Research Coordinator Associate
Clinical Research Coordinator Associate
Job Number: 78130
The Biobehavioral Pediatric Pain (BPP) Laboratory in the Department of Anesthesiology, Perioperative and Pain Medicine is seeking a full-time Clinical Research Coordinator Associate (CRCA). The primary focus of the lab involves the assessment and treatment of psychological aspects and neural underpinnings of chronic pain in children and adolescents with chronic pain. The CRCA will be primarily involved with BPP but will also interact with other clinicians and researchers across labs and settings. The CRCA will be involved with several ongoing projects that involve questionnaire, physiological, and MRI brain imaging data acquisition and collection from children and adolescents with chronic pain, including treatment intervention study and fMRI research.
Stanford University, located between San Francisco and San Jose in the heart of California's Silicon Valley, is one of the world's leading teaching and research universities. Since its opening in 1891, Stanford has been dedicated to finding solutions to big challenges and to preparing students for leadership in a complex world.
Supporting that mission is a staff of more than 10,000, which is rooted in a culture of excellence and values innovation, collaboration, and life-long learning. To foster the talents and aspirations of our staff, Stanford offers career development programs, competitive pay that reflects market trends and benefits that increase financial stability and promote healthy, fulfilling lives. An award- winning employer, Stanford offers an exceptional setting for professionals looking to advance their careers”
- Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. Primary contact for participants in the Learning and Memory study and other studies in the Biobehavioral Pediatric Pain (BPP) Lab. Determine/make decisions regarding eligibility for participants, study protocols, and compliance issues based on IRB and other regulatory agencies.
- Manage data and evaluate effectiveness and make recommendations to the PI for any changes needed throughout the study. Maintain accuracy and completeness of data collections and integrity.
- Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies. Consent participants for the Learning and Memory study and additional BPP lab studies. Responsible for evaluating recruitment options and success and for making changes in recruitment methods to increase participant enrollment when needed.
- Coordinate collection of study specimens and processing. Coordinate and/or perform behavioral testing, neuroimaging scans, behavioral data questionnaires, and saliva sample collection.
- 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. Independently collects and manages patient data; manage database and develop CRF's, patient tracking tools, and study documents. Must be experienced and able to design and implement study documents and understand Stanford clinical trial study requirements/regulations in order to accurately handle/process informed consents, study questionnaires, and screening tools.
- 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. Responsible for documentation/data management for BPP projects; serve as resource to other team members to maintain/monitor privacy of data as well as providing training on regulatory process/requirements as needed. Responsible for reporting protocol deviations to the IRB; notify PI of any issues regarding privacy for further action.
- Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. May supervise work of students to assemble study kits and scheduling of study participants; must be able to lead lab meetings, communicate study progress, and present data (meetings are not with participants).
- Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. Develop and provide status reports to PI; propose solutions to any problem related to safety. Monitor participants for any adverse events related to participant health status and reports to PI; provides reports related to recruitment, quarterly reports often required by IRB or funding source.
- 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.
- Knowledge of principles of clinical research and federal regulations.
- Ability to effectively work in a fast paced environment with multiple projects and timelines.
- Familiarity with IRB guidelines and regulations.
- Previous experience with SPSS and other related database applications.
- Familiarity with Unix command line navigation or basic scripting knowledge.
- Previous experience working with children and families.
- Experience/knowledge of quantitative sensory testing.
- Experience/knowledge of neuroimaging.
- Minimum of one year related 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.
- Strong interpersonal skills.
- Proficiency with Microsoft Office.
- Knowledge of medical terminology.
- 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.
Occasional evening and weekend hours.
Location: School of Medicine
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.