Clinical Research Associate I, IQVIA Biotech - Nationwide United States

IQVIA•Durham, KS

21h•Remote

About The Position

This position is part of a company training program designed to equip individuals with the necessary knowledge and skills to independently conduct clinical monitoring visits. The role involves extensive training with enhanced oversight and dedicated mentoring from senior Clinical Research Associates (CRAs) and Managers. The goal is to ensure adherence to study protocols, standard operating procedures, good clinical practices, and applicable regulatory requirements.

Requirements

Knowledge of clinical research process and medical terminology.
Experience in clinical research and/or coordinating clinical trials.
Experience in oncology, biopharma, cardiovascular, metabolic, or renal studies.
Good organizational, problem-solving, and interpersonal skills.
Effective time management skills.
Ability to reason independently and recommend specific solutions in clinical settings.
Good written and verbal communication skills, including a good command of the English language.
Ability to collaborate and communicate with a variety of colleagues and customers.
Computer skills including proficiency in Microsoft Word, Excel, and PowerPoint.
Proficiency in the use of a laptop computer.
Ability to qualify for a major credit card (US Only).
Valid driver’s license.
Ability to rent an automobile.
Clinical research coordination experience at the site level.
Nursing or University Degree (US Bachelor Level or equivalent) in one of the life sciences.
Equivalent combination of education, training, and experience.

Nice To Haves

Knowledge of electronic data capture preferred.

Responsibilities

Complete therapeutic, protocol, clinical research, SOP, and systems training.
Gain experience in study procedures by working with experienced clinical monitoring staff.
Perform site selection, initiation, monitoring, and close-out visits under close supervision.
Learn key facets for developing a project subject recruitment plan on a per-site basis.
Suggest ideas to CRA and/or CTM for improving site recruitment plans.
Assist CRA and/or CTM in tracking subject site recruitment progress.
Administer protocol and related study training to assigned sites.
Establish regular communication with sites to manage project expectations and issues.
Convey study features and opportunities to the site.
Evaluate the quality and integrity of study site practices.
Escalate quality issues as appropriate.
Create and maintain documentation regarding site management, monitoring visit findings, and action plans.
Manage study progress by tracking regulatory submissions, recruitment, CRF completion, and data query resolution.
Support the start-up phase under close supervision.
Collaborate and liaise with study team members for project execution support.