Research Assistant

JOB TITLE:        Research Assistant – Patient Screening and Administrative Support

REPORTS TO:    Vice President

FLSA STATUS:    Exempt     

JOB SUMMARY: 

We are seeking a detail-oriented and motivated Research Assistant to join our clinical trial team. The Research Assistant will play a crucial role in the initial screening of patients for eligibility and provide administrative support to ensure the smooth operation of clinical trials. This position is ideal for someone with excellent communication skills, a strong organizational mindset, and a passion for contributing to groundbreaking medical research.

Key Responsibilities

Patient Screening and Recruitment:

• Conduct initial pre-screening of potential trial participants based on study-specific inclusion/exclusion criteria.
• Communicate with patients via phone, email, or in person to collect pre-screening information and provide trial-related details.
• Maintain accurate and confidential records of patient screening data.
• Schedule screening visits and follow-ups as needed in coordination with study timelines.

Administrative Support:

• Assist in maintaining and organizing study-related documentation, including informed consent forms, case report forms, and regulatory binders.
• Ensure compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements in all administrative tasks.
• Coordinate appointments, meetings, and communication between investigators, staff, and sponsors.
• Manage data entry and ensure accuracy within clinical trial management systems (CTMS).

Study Coordination Assistance:

• Support Clinical Research Coordinators (CRCs) and Principal Investigators (PIs) in daily trial activities.
• Prepare and maintain patient files and source documents.
• Track inventory and order supplies needed for clinical trials.
• Assist in monitoring participant adherence to study protocols and follow-up schedules.

Regulatory and Compliance:

• Adhere to study protocols, sponsor requirements, and regulatory standards.
• Participate in site audits and inspections as needed.
• Contribute to staff training sessions on administrative procedures or protocol updates.

Qualifications

Required:

• Excellent organizational and multitasking skills.
• Strong written and verbal communication abilities.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook) and familiarity with database systems.
• Commitment to maintaining patient confidentiality and adhering to ethical standards.

Preferred:

• Bachelor’s degree in a related field (e.g., health sciences, life sciences, or a similar discipline).
• Experience working in a clinical research or healthcare setting.
• Knowledge of medical terminology and clinical trial processes.
• Familiarity with Clinical Trial Management Systems (CTMS) or electronic data capture systems.