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Clinical Research Assistant- MA

The Clinical Research Assistant provides assistance in clinical research studies. Will be responsible for collecting and organizing patient data, performing clinical tests, and maintaining and updating data generated by the study. Responsible for assisting with coordination of clinical trials including initiation, monitoring, reporting, and close out activities. Assists in collection and processing of blood and tumor samples. Assures that the processes, integrity, and quality of the research is assessed and maintained, and that the trial is conducted in accordance with Good Practice Guidelines, federal and sponsor regulation guidelines, and Verdi Policy and Procedures. Has knowledge and understanding of the research operations.

Position Details:

The Clinical Research Assistant provides assistance in clinical research studies. Will be responsible for collecting and organizing patient data, performing clinical tests, and maintaining and updating data generated by the study. Responsible for assisting with coordination of clinical trials including initiation, monitoring, reporting, and close out activities. Assists in collection and processing of blood and tumor samples. Assures that the processes, integrity, and quality of the research is assessed and maintained, and that the trial is conducted in accordance with Good Practice Guidelines, federal and sponsor regulation guidelines, and Verdi Policy and Procedures. Has knowledge and understanding of the research operations.

Reports to:

Clinical Research Project Manager/Assistant Director of Clinical Research

Major Functions:

· Assists with site start up and closeout activities

· Consents patients to participate in research trials

· Screens and enrolls patients to clinical trials

· Maintains continuing communication with the study participants to ensure their understanding of the study protocol, procedures, and requirements to ensure accurate study compliance

· Assists with completing study visits with patients as defined by the study protocol by providing thorough review and documentation at each visit

· Assists in performing vital signs, electrocardiograms (EKGs), and other study procedures

· Accurately records source documentation in site electronic medical record (EMR) and study electronic data capture (EDC) systems

· Monitors and documents adverse events (AEs) in the EMR

· Maintains thorough source documentation by ALCOA guidelines in the EMR

· Assists with preparation for patient study visits

· Notifies Clinical Research Project Managers and Principal Investigators of all serious adverse events (SAEs) and deviations

· Participates in the reporting process of SAEs and deviations

· Performs inventory of all study supplies (lab, investigational product, etc.)

· Assists with collection, processing, and shipment of specimens

· Assists with data entry and query resolution as needed

· Participates in monitoring visits

· Maintains continuous communication with Clinical Research Coordinator and Clinical Research Project Manager

· Participates in audits and inspections for internal/CRO/Sponsor/FDA inspections

· Ensures compliance with federal, state, and organizational guidelines regarding clinical research protocols

· Promotes Good Clinical Practices (GCP) in the conduct of clinical trials by possessing an in-depth knowledge of Federal Regulations and Guidance documents for the conduct of clinical trials and human subject protection

Qualifications:

· Current MA license

· Excellent verbal and written communication skills

· Critical thinking skills

· Ability to track and perform multiple tasks

· Ability to manage large volumes of information

· Previous Oncology experience recommended

· Previous Clinical Research experience recommended
Physical Requirements:

· Able to lift 10 pounds for routine performance of essential functions.

· May have long periods of sitting and/or standing and walking.

· Frequent use of phone and computer.

· May be exposed to adverse indoor and outdoor environmental conditions, bloodborne pathogens, physical hazards (e.g., needle pricks, etc.) and chemical hazards.

This is not necessarily an all-inclusive list of job-related responsibilities, duties, skills, efforts, requirements or working conditions. While this is intended to be an accurate reflection of the current job, management reserves the right to revise the job or to require that other or different tasks be performed as assigned.

Come as you are. Here at Verdi Oncology, Inc, we want everyone to feel comfortable being their true, authentic selves at work. This means that we make all employment decisions based on business need, job requirements, and individual qualifications without regard for race, gender, gender identity, sex, color, ethnicity, religion, family or parental status, disability, veteran or military status, or any other statuses protected by Federal laws or regulations or those in the locations where we operate. We are committed to maintaining a workplace that is free of discrimination, harassment, and/or retaliation for all members of the team.

All job requirements are subject to possible revision to reflect changes in the position requirements or to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a threat or risk to the health and safety of themselves or other employees. This job description in no way states or implies that these are the only duties to which will be required in this position. Employees will be required to follow other job-related duties as requested by their supervisor/manager (within guidelines and compliance with Federal and State Laws). Continued employment remains on an “at-will” basis.

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