Clinical Research Coordinator I

Job Description

The Clinical Research Coordinator I supports and manages daytoday activities for clinical research studies, ensuring strict compliance with FDA regulations, GCP guidelines, sponsor protocols, and IRB requirements. This role partners closely with investigators, sponsors, CROs, and participants to ensure accurate execution, documentation, and successful study completion.

Key Responsibilities

Ensure compliance with FDA, GCP, IRB, sponsor, and protocol requirements

Manage protocol deviations, informed consent, SAE and AE reporting

Coordinate clinical trials from startup through closeout

Collect and document clinical data (vitals, EKGs, height, weight, etc.)

Perform phlebotomy, specimen collection, processing, storage, and transport

Obtain and review medical records as required

Educate participants on study expectations, diaries, and medication restrictions

Conduct patient phone visits per protocol requirements

Maintain accurate, timely documentation in compliance with ALCOA standards

Communicate with sponsors, CROs, monitors/CRAs, IRBs, labs, and site personnel

Support monitor visits and maintain study readiness

Manage study inventory and order supplies as needed

Travel to investigator meetings as required

Promote teamwork, flexibility, and support tasks outside regular duties

Occasional evenings, weekends, and overtime may be required

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Skills and Requirements

1+ year of clinical research experience

Formal medical training, healthcare education, or handson clinical experience

Strong knowledge of medical terminology

Ability to perform clinical and diagnostic procedures (vitals, labs, etc.)

Experience with AE/SAE reporting and informed consent preferred

Strong organizational, multitasking, and timemanagement skills

Excellent written, verbal, and interpersonal communication skills

Proficient with office software and site documentation systems

Ability to work independently in a fastpaced research environment

Ability to be ambulatory most of the day and lift/manipulate equipment as needed