Clinical Research Assistant

Overview

The Clinical Research Assistant plays a key role in assisting with the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary function of the Clinical Research Assistant is to support the Clinical Research Coordinators (CRCs) and the broader study team in the successful execution of clinical trials to achieve study objectives and corporate goals.

This role is responsible for a variety of tasks, including administrative duties, data management/entry, patient interaction and technical procedures such as phlebotomy, performing ECGs and vital signs. Additional focus is on specimen collection, specimen handling and transport, specimen processing, lab manual creation, reviewing lab results and inventory monitoring.

• Maintain a safe, clean working environment, including infection control requirements
• Perform specimen collections, includes venipuncture to pediatric and adult participants
• Process specimens received in the laboratory. This task includes specimen transport, handling, sorting, requisition entry, inventory accountability, and reviewing lab results for PI review.
• Performing CLIA waived testing such as urine pregnancy testing, urine dip analysis, urine drug screen testing, alcohol testing, Rapid Antigen Testing
• Ensure specimen collection/processing/shipping are performed according to protocol
• Complete study training and available for additional duties to support study conduct as needed, which may include:
• Assist with the screening, recruiting and enrollment of research subjects
• Assist in the informed consent process of research subjects
• Collect patient/research participant history
• Data entry and Management per Good Documentation Practice
• Coordinate follow-up care and laboratory procedures
• Support the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, non-¬ clinical supply materials, imaging and laboratory handling manuals, etc.)
• Performing vitals, ECG, spirometry
• Coordinate protocol related research procedures, study visits, and follow-¬up care
• Develop strong working relationships and maintain effective communication with study team members
• Develop strong working relationships with the investigators and staff to build a foundation of trust and respect
• Adhere to an IRB approved protocol
• Support the safety of research subjects
• Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines
• Perform other duties as required and/or assigned

• Experience with Athena EMR preferred
• Clear and concise written and oral communication skills to interact effectively with coworkers and study staff (including sponsor/CRO).
• Strong organizational skills including the ability to accomplish multiple tasks within established time frames through effective prioritization of duties and functions in a fast-paced environment.
• Ability to recognize and synthesize information
• Ability to act and operate independently with minimal daily direction from manager to accomplish objectives
• Strong attention to detail and accuracy
• Excellent interpersonal and customer relationship skills
• Aptitude to work effectively and positively with a team and diverse group of individuals
• Basic skill level with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint)
• Basic knowledge of medical terminology preferred

• Bilingual (English/Spanish) required
• Minimum 1 year of experience in clinical research or a patient facing, clinical setting
• Associates degree a plus
• Certification in phlebotomy, ECGs or similar clinical skills preferred