Clinical Research Coordinator

Description

We are looking for an experienced CRC to support our dermatology studies. This role is in-person, 5 days a week, and the individual should be able to drive. We are looking for coordinators who have experience with screening using an EMR, source documentation, IP accountability, managing own IP, working with research pharmacy, centrifuging and handling biological samples, shipping, EDC experience, regulatory experience including study start-up to study closure and all communication in between, source data verification, CTMS, and AE reporting, to name several critical responsibilities.

Responsibilities

• Responsible for coordination of a designated study or group of studies.
• In research projects, oversees recruitment of subjects, implementation of study procedures, and the collection and processing of data.
• Keeps accurate and up-to-date records.
• Collects labels, logs, processes, and ships biological specimens for analysis according to protocol and training requirements.
• Schedules subjects for protocol-related evaluations; collaborates with physicians, investigators and other healthcare providers; promotes respect for subjects' rights.
• Administers, scores and evaluates results of assessments as assigned and as related to study protocol; collects data, confers with PI and forwards results to sponsor (internal or external).
• Interfaces with external agencies as necessary; organizes all phases of grant process for submission to funding agencies as necessary.
• Ensures availability of drug supplies and / or equipment for studies; maintains drug accountability logs.
• Liaisons with agencies and pharmaceutical companies, laboratories, and equipment and supply companies, as needed.
• Adheres to good clinical practice, and complies with regulatory and grant agency requirements; follows protocol as developed and keeps investigator or supervisor informed of developments.
• Collaborates with PI and the food and drug administration and drug companies on related issues; may be required to perform phlebotomy, electrocardiograms, or monitor vital signs on study participants and report findings to supervisor.
• Operates under general guidance and work assignments are varied and require interpretation and independent decisions on course of action.
• Performs related duties as required. All responsibilities noted here are considered essential functions of the job under the Americans with Disabilities Act. Duties not mentioned here, but considered related are not essential functions.