Clinical Research Coordinator 2
Clinical Research Coordinator 2🔍School of Medicine, Stanford, California, United States📁Research📅Nov 11, 2020 Post Date📅87767 Requisition #Stanford University’s Skin Innovation and Interventional Research Group (SIIRG) in the Department of Dermatology is seeking a Clinical Research Coordinator 2 (CRC2) to perform duties related to the coordination of clinical studies. The CRC2 will work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies. The CRCA will support federal and non-federal clinical research studies including dermatological and investigative work in support of clinical trials, clinical research or biomedical research focusing on “bench to bedside” treatment.Duties include:
- Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work. Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.Ensure regulatory compliance. Regularly inspect study document to ensure ongoing regulatory compliance.Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.
- Excellent oral and written communication skills
- Experience with managing clinical data entry and capture in a research setting
- Proficiency in using computers, software, and web-based applications in a previous administrative setting
- Experience training others on topics related to clinical research conduct and management
- Strong interpersonal skills
- Proficiency with Microsoft Office and database applications.
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
- Knowledge of medical terminology.
- 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.
- 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 diseases and infections.
- May require extended or unusual work hours based on research requirements and business needs.
- 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.
- Schedule: Full-time
- Job Code: 4923
- Employee Status: Regular
- Grade: H
- Department URL: http://dermatology.stanford.edu
- Requisition ID: 87767