Float Clinical Research Assistant

Title: Float Clinical Research Assistant

Position: Full-Time, Hourly

Based at: TCR - Charleston

Position Summary: The Clinical Research Assistant plays a key role in supporting Clinical Research Coordinators and Principal Investigators with Phase II–IV clinical trials, ensuring compliance with international research standards and regulations. This people-centered position is perfect for someone with a warm, approachable personality who enjoys working with diverse individuals. The role offers a great opportunity to learn and grow in a collaborative environment, with close supervision and guidance from experienced professionals.

Key Skills and Competencies:

·       Experience: 0-1 year. Actively learning GCP, IATA standards, and SOPs; begins CMA certification training process if not previously completed.

• Strong understanding of medical and clinical research terminology.
• Excellent verbal, written & interpersonal skills.
• Exceptional attention to detail and accuracy.
• Checklist-based training on general clinical assessments and core research skills to ensure procedural consistency and team readiness.
• Proficiency in Data Management and Informatics.
• Adhere to Principles of Ethical Research Standards.
• Highly organized individual with strong time management skills.
• Continuous learning mindset and commitment to professional development.

Primary Accountabilities:

·       Recruit, screen and assist with enrolling study participants according to protocol requirements.

·       Obtain various biological samples, process and ship, as necessary and dependent on site specific needs.

·       Collect, record and maintain accurate study data in compliance with Good Clinical Practice.

·       Conduct medical record review.

·       Support participants throughout the study by answering inquiries, reinforcing study protocols, and escalating concerns to clinical staff when needed.              

General Accountabilities:

·       This role involves regular travel among the West Ashley & Goose Creek sites.

·       Collaborate with investigators, clinicians, quality assurance and sponsors.

·       Schedule and coordinate participant visits, assessments and follow-ups.

·       Input patient data into company systems.

·       Oversee organization and workflow of trials with meticulous attention to detail and ordering of priorities.

·       Navigate and address sponsor and study issues to resolution.

·       Maintenance of organized, complete study charts, and legible, accurate research documentation through written progress notes.

·       Have working knowledge of protocol including background, rationale, and description of investigational drug/device.

·       Thorough knowledge of Inclusion/Exclusion criteria with Investigator available for questions.

·       Submit all regulatory documents and correspondence to regulatory personnel in a timely manner.

·       Identify protocol problems and inform TCR Research Team of problems limiting recruitment and work on strategies to overcome these problems.

·       Participate in weekly site meetings.

·       Facilitates clear and consistent communication among clinical trial teams through phone, email, and face-to-face interactions to ensure alignment on procedures, updates and patient care.

·       Actively engages in cross training- including phlebotomy and interdepartmental collaboration to enhance versatility and comprehensive support during patient procedures.

·       Knowledge of the research process, the importance of adherence to protocols, and the accuracy needed in collection and documentation of research data.

·       Ability to read and understand the protocol, including any amendments, to ensure familiarity with study procedures and an understanding of the potential risks and side effects of the investigational product.

·       Ability to interact daily with physicians, nurses, study monitors and other sponsor representatives, administrators and other employees, community resources, patients and their families and significant others.

This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties. Responsibilities, tasks, and duties of the job holder might differ from those outlined in the job description and other duties, as assigned, might be part of the job.

A person in this position must be highly organized, utilize excellent verbal and written communication and be able to multi-task. This position requires excellent time management and communication skills and confidentiality. This position may require travel, lifting (up to 50 pounds), sitting, standing, and walking associated with a normal clinical research / physician office environment. A person in this position may be exposed to fumes, airborne particles, infectious diseases, blood/bodily fluids, and disease-bearing specimens.

This position requires adherence to Tribe Clinical Research’s Core Values as outlined:

·       We are passionate about working for a GROWTH ORIENTED company.

·       We exhibit a HUMBLE but CONFIDENT approach to work.

·       We communicate what needs to be said RESPECTFULLY.

·       We love serving others and WORKING TOGETHER for the greater good.

·       We can take constructive feedback well and have a POSITVE ATTITUDE even when the going gets tough.

Reporting Structure: Site Lead