Graduate Student Research Assistant I Orthopedics

About the position

The Clinical Research Assistant I (RA I) will assist the Clinical Research Coordinators (CRC)/Research Nurse in the conduct of Phase I-IV industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, FDA Regulations, and ICH/GCP Guidelines. The RA I is immediately accountable to the CRC/CRN and works with them and other study team members to meet study-specific goals and timelines and communicates appropriately and effectively with subjects, investigators, CRC's and other staff. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

Responsibilities

• Delivers safe care and demonstrates regard for the dignity and respect of all participants.
• Practices the principles of Universal Precautions.
• Understands and abides by HIPAA regulations.
• Conforms to all standards of good research practice and provides support to research patients by abiding current IRB, FDA, federal, state and institutional regulations pertaining to human subjects research.
• Assists the CRC/CRN by communicating patient events and concerns regarding the patient's level of understanding.
• Functions as a patient advocate by escalating patient concerns to the CRC/CRN.
• Assists the CRC/CRN in maintaining neat, organized, accurate, and up-to-date source document records for all participants.
• Completes Case Report Forms (CRF's) or subject tracking tools in a timely manner.
• Ensures that all data collection meets protocol specifications and requirements.
• Has a basic understanding of protocol documents and performs required activities with the assistance of the CRC/CRN.
• Communicates with the CRC/CRN incoming data and patient status such as adverse events and inconsistencies.
• Assists with source document completion for all required/reported data.
• Submits data in the time frame specified.
• Assists with the maintenance of study chart to coincide with current patient status.
• Maintains a clean, prepared clinical space.
• Performs set-up and turnover procedures in all clinical areas, per SOPs and/or Working Instructions, in a timely manner.
• Contributes to providing the highest levels of customer service by maintaining open communication with other research staff.
• Participates in inter and/or intradepartmental discussions relevant to research.
• Performs other duties as assigned or directed to ensure the smooth operation of the department.

Requirements

• High school diploma or equivalent

Nice-to-haves

• Lab Processing
• Phlebotomy
• Computer skills, particularly Microsoft Outlook, Word, Excel, PowerPoint, use of internet and other research tools
• Knowledge of clinical research
• Communication skills in Spanish (writing, speaking and comprehending)

Benefits

• Benefits from Day One
• Paid Days Off from Day One
• Career Development
• Whole Person Wellbeing Resources
• Mental Health Resources and Support
• Pet Insurance
• Debt-free Education (Certifications and Degrees without out-of-pocket tuition expense)