Assistant Clinical Research Coordinator/Equipment Supervisor

Frontage Laboratories•Secaucus, NJ

6d•$25•Onsite

About The Position

The Assistant Clinical Research Coordinator Assists the Clinical Research Coordinator in developing strategies for implementing study procedures in compliance with the study protocol.

Requirements

At least 6 months’ experience supporting clinical research study conduct.
Must possess a general knowledge of applicable clinical research regulatory requirements; general knowledge of GCP and ICH guidelines is preferred.
Strong computer skills including proficiency in use of Microsoft Word, Excel, and PowerPoint.
Strong written and verbal communication skills.
Effective time management and organizational skills.
Attention to detail and accuracy in work.
Knowledge of applicable protocol requirements.

Nice To Haves

General knowledge of GCP and ICH guidelines

Responsibilities

Develops a high level of familiarity and knowledge of the study protocol and flow chart of study procedures.
Develops a strategy for implementing study procedures in compliance with the study protocol.
Performs study procedures (e.g., obtain ECG recordings, vital signs, safety assessments, etc.) as required by study protocol under the supervision of the Clinical Research Coordinator, Principal Investigator, and Sub-Investigators.
Records study data in the source documents. Evaluates and reviews study data to ensure accuracy and completeness.
Assists the clinic team in transcribing study data from source documents to sponsor designated electronic case report forms.
Resolves data queries in conjunction with the sponsor.
Assists the Principal Investigator with gathering and recording relevant data for adverse event reporting and expedited reporting of serious adverse events to the sponsor.
Assists with preparation of protocols, informed consents, amendments and other necessary documents for review by the sponsors and IRB.
Assists in the administration of informed consent to research subjects under the supervision of the Principal Investigator.
Maintains investigator/sponsor files in accordance with the FDA and GCP Guidelines.
Assists in the screening of research subjects to evaluate their eligibility for a clinical study.
Creates and performs QC procedures.
Establishes and maintains source documentation for study protocols in conjunction with the Principal Investigator and Sub-Investigators.
Other assigned.