Benefits:

401(k)

Competitive salary

Opportunity for advancement

Training & development

Job Summary

We are seeking a detail-oriented and experienced Unblinded Coordinator to join our clinical research team. The Unblinded Coordinator will play a critical role in maintaining the integrity of our clinical trials by managing all unblinded activities. This position requires strict adherence to protocol and regulatory requirements to ensure that the study's blind is not compromised.

Key Responsibilities

Manage Unblinded Activities: Handle all unblinded aspects of the clinical trial, including randomization, drug dispensation, and communication with blinded and unblinded staff.

Drug Accountability: Track and document the receipt, storage, and dispensation of investigational products, ensuring compliance with regulatory requirements.

Documentation: Maintain accurate and detailed records of unblinded activities, including drug inventory logs, dosing records, and any deviations from the study protocol.

Collaboration: Work closely with the study team, including investigators, pharmacists, and study coordinators, to ensure proper management of the investigational product.

Protocol Compliance: Ensure that all unblinded procedures are conducted in strict accordance with the study protocol, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements.

Confidentiality: Maintain the confidentiality of the study blind and ensure that no information that could potentially unblind the study is inadvertently disclosed.

Communication: Serve as the primary point of contact for unblinded queries and issues, and facilitate communication between the blinded and unblinded teams as necessary.

Audit Preparation: Assist in preparing for and participating in study audits and inspections related to unblinded activities.

Qualifications

Experience: Minimum of 2 years of experience in clinical research, with specific experience in drug accountability or unblinded roles preferred.

Knowledge: Strong understanding of GCP, FDA regulations, and clinical trial protocols. Familiarity with investigational product management and randomization procedures.

Skills:

Excellent attention to detail and organizational skills.

Strong written and verbal communication skills.

Ability to work independently and as part of a team.

Proficiency in Microsoft Office Suite and clinical trial management systems (CTMS)