Clinical Research Nurse Coordinator I

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Work with the principal investigator or other co-investigator(s) on clinical research studies
• Assure compliance with the protocol requirements as mandated by the sponsor, our Standard Operating Procedures (SOPs), local and/or central Institutional Review Boards (IRB), and the U.S. Food and Drug Administration (FDA)
• Provide nursing care to research study patients:
• Participates in recruitment and selection of study participants by interviewing and documenting medical history to determine eligibility requirements for each study
• Performs medical tests, including but not limited to vital signs, imaging studies, electrocardiograms, IV line insertion, and blood draws
• Administers investigational medications and performs patient assessments during clinic visits to determine presence of side effects and notifies Principal Investigator accordingly
• Provide education and information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment
• Documents medical and study data appropriately in patient charts/source documents to capture study requirements
• Ensures assigned studies are conducted in accordance with FDA, OSHA, and Good Clinical Practice (GCP) guidelines in the following capacities:
• Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
• Develops accurate and appropriate source materials and ensures compliance from site staff
• Provides accurate and timely data collection, documentation, and reporting in both sponsor and site databases
• Ensures appropriate credentialing and training of all staff members delegated to each study
• Supports the regulatory staff in the maintenance of regulatory documents in accordance with SOPs and applicable regulations
• Interfaces with research subjects to support efforts to determine eligibility and consenting according to each protocol
• Communicates study-specific requirements to the research team, including internal and external parties, sponsors, monitors, Principal Investigator and study subjects
• Provides ongoing quality control audits including maintaining investigational drug and device accountability
• Collaborates with study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance

QUALIFICATIONS

• Expert at starting IVs, pediatric experience highly desirable
• Knowledge of accepted clinical research practices, including universal precautions, GCP, human subjects research protocols, and HIPAA requirements
• Knowledge of medical terminology and drug dosage calculation
• Ability to work independently and with careful attention to detail
• Excellent multi-tasking, organizational skills and ability to manage deadlines under pressure
• Excellent oral and written communication skills
• Ability to identify and solve problems with demonstrated initiative
• Proficiency in Microsoft Office, electronic health systems and databases used in research environments
• Must be able to establish rapport and communicate with subjects of diverse cultural and educational backgrounds.

EDUCATION AND EXPERIENCE

• Current RN license
• Bachelor of Science in Nursing or other scientific disciplines desired
• At least one year of experience in clinical research settings
• CCRC or other clinical research certification desired

LANGUAGE SKILLS

• The ability to read, write, and speak English clearly is mandatory
• The ability to interpret documents such as safety rules, SOPs, and procedures is critical
• An understanding of and ability to communicate in scientific language is desired
• Spanish proficiency and/or fluency desired

PHYSICAL DEMANDS

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job
• The incumbent is regularly required to sit, talk, hear, and climb stairs
• The incumbent frequently is required to use hands to finger, handle or feel equipment, paper, or files
• The incumbent is required to stand, walk, and reach with hands and arms
• The employee must occasionally lift and/or move up to 10-20 pounds

BENEFITS

• Competitive Salaries: Attractive compensation aligned with industry standards
• Ongoing Training and Development: Access to programs that promote continuous learning and opportunities for career advancement
• Health Insurance: 100% employer-paid premiums for the employee's medical (Anthem PPO plan), dental, vision, life, and long-term disability insurance plans
• Dependent Coverage Support: An additional $300 per month towards dependent medical insurance premiums
• Supplemental Benefits: Opportunities to purchase supplemental life and critical care insurance at a reduced cost
• Retail Plan: A 403(b) retirement plan with a discretionary company match to help secure your financial future
• Generous Paid Time Off: Enjoy 15 vacation days, 11 paid holidays, and 2 floating holidays each year
• Inclusive Work Environment: Be part of a collaborative workplace that values diversity and inclusion

COMPENSATION

• The salary range for this role may vary above or below the posted range as determined by education, experience, and specialized certifications
• Compensation takes into account several factors including but not limited to a candidate’s experience, education, skills, licensure and certifications, department equity, training and organizational needs
• Base pay is just one piece of the total rewards program offered by SDRI. Eligible roles also qualify for a comprehensive benefits package