Medical Assistant- Research

American Oncology Management Company; Fort Myers (FL); Hybrid; USD 25,000 - 39,000; Full time

Job summary

Florida Oncology and Hematology is seeking a Clinical Research Coordinator I (non-RN) to support the conduct of multiple oncology trials under medical supervision. You will manage entry-level study procedures, data entry, and regulatory tasks with a focus on quality and adherence to GCP/ICH/FDA guidelines.

The role emphasizes protocol comprehension, patient coordination, AE reporting, and collaboration across sites.

Qualifications

• High school education required; some college preferred.
• Prior research or related medical science experience.
• Proficiency with MS Office; EMR and trial-data systems experience preferred.

Responsibilities

• Coordinate care for patients on clinical research protocols under GCP/ICH/FDA guidance.
• Assist with protocol feasibility assessments and site questionnaires.
• Identify inclusion/exclusion criteria, prescreening, screening and re-screening.
• Assist with informed consent process and documentation.
• Review diagnostic tests and trial-related documentation.
• Capture and report adverse events and manage investigational product handling.
• Maintain regulatory compliance and prepare monitoring documentation.

Skills

Analytical thinking

Interpersonal effectiveness

Communication skills

Customer service

Self-management

Multi-site coordination

Education

High school education

Some college

Tools

MS Office

EMR

EDC

CTMS

Job description

Location:

Florida Oncology and Hematology

Hiring Range:

$18.00 - $28.08

Job Description Summary

Responsible for the performance of the research study under the medical supervision of the Principal Investigator. The Clinical Research Coordinator I (non-RN) is responsible for the overall successful implementation and ongoing management of the research studies. Ability to perform basics tasks and exhibit the knowledge of key aspects of clinical research at an essential or foundational level

Primary responsibility includes study designs with entry-level complexity (phase 4, observational/registry trial design) and associated study procedures. Administratively and clinically manage an average 5 clinical trials open to accrual annually and/or active (on study treatment) patient volume 2-10 annually.

Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.

Primary Key Performance Areas

KPA 1 - Protocol Comprehension and Implementation: Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements.

• Identify and explain key protocol elements and perform study tasks under direct supervision.
• Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires.
• Identifies and explains inclusion/exclusion criteria and the process of subject identification, prescreening, screening and re-screening.
• Knowledge of the required elements of an informed consent form and the essential elements of the informed consent process.
• Review of diagnostic tests and related documentation required per protocol.
• Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events. Document different types of adverse events under direct supervision.
• Ensures proper storage, dispensing, handling and destruction processes for investigational products.
• Follows process for handling investigational products that have been compromised.

KPA 2 - Regulatory and Data Integrity

• Follows Institutional Review Board (IRB) / Independent Ethics Committee (IEC) review, approval and reporting requirements for the site. Maintains site credentials and ensures updated GCP, licenses remain on file.
• Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC.
• Collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient's medical record for completeness and accuracy under direct supervision.
• Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.
• Prepare documents for monitoring visits under direct supervision. Review visit monitoring follow-up reports / letters and perform requested activities.
• Escalates issues of protocol non-compliance to study PI and research department leadership.

KPA 3 - Research Financial Practices: Budget/Contract execution and practices research billing compliance

• Identifies elements of a study budget as it relates to execution of a protocol.

Position Qualifications/Requirements

Education

• High school education required.
• Some college is preferred.

Previous Experience

• Prior research or related medical science experience.

Core Capabilities

• Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.
• Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.
• Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.
• Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.
• Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remote effectively as required.
• Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.

Computer Skills

• Proficiency in MS Office Word, Excel, Power Point, and Outlook required.
• Prior experience with electronic medical records (EMR) is preferred.
• Prior experience with clinical trial data entry systems (EDC) preferred.
• Prior Clinical Trial Management Systems (CTMS) preferred.

Travel

0%

Standard Core Workdays/Hours: Monday to Friday 8:00 AM - 5:00 PM.