Research Assistant

Gastromed,-LLC; Kendall (FL); On-site; USD 40,000 - 58,000; Full time

Job summary

Gastromed,-LLC is seeking a Research Assistant to support patient screening and administrative tasks for clinical trials in Kendall, FL. The role emphasizes meticulous data handling, regulatory compliance, and strong communication with patients and study teams.

Responsibilities include screening participants for eligibility, coordinating visits, maintaining documents, and ensuring accurate CTMS data entry. The successful candidate will be organized, detail-oriented, and committed to GCP

Qualifications

• 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.

Responsibilities

• 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.
• Assist in maintaining and organizing study-related documentation, including informed consent forms and case report forms.

Skills

MS Office proficiency

Database systems familiarity

Excellent communication

Organizational skills

Education

Bachelor's degree in health sciences or related field

Tools

CTMS knowledge

EDC systems knowledge

Job description

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.