Assistant Clinical Research Coordinator

Assistant Clinical Research Coordinator

Title: Assistant Clinical Research Coordinator

Location: Secaucus, NJ, onsite

Reports to

Manager of Clinical Operations.

Full-time/ Hourly

Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position/Job Summary

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

Roles & 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.