Research Assistant

Gastromed, LLC.; Kendall (FL); On-site; USD 42,000 - 64,000; Full time

Job summary

Gastromed, LLC. in Kendall, FL is seeking a detail-oriented Research Assistant to support patient screening and administrative tasks within our clinical trial team.

You will conduct pre-screening, maintain confidential data, schedule visits, and support regulatory filings, while ensuring GCP compliance and effective communication with investigators and sponsors. This role offers exposure to groundbreaking medical research and requires strong organizational and communication skills, plus

Qualifications

• Excellent organizational and multitasking skills.
• Strong written and verbal communication abilities.
• Proficiency in Microsoft Office Suite 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 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 in coordination with study timelines.
• Assist in maintaining and organizing study-related documentation, including informed consent forms and case report forms.
• Ensure compliance with 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 CTMS.
• Support Clinical Research Coordinators and Principal Investigators 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.

Skills

Organizational skills

Multitasking

Communication skills

MS Office

Data entry

CTMS familiarity

Education

Bachelor’s degree in health or life sciences

Tools

CTMS

EDC systems

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.