Clinical Research Associate – Part time Contractor

This is a fully remote position, open to applicants in United States.

📋 Description

• Engages in assigned studies to ensure the protection of human subjects, adherence to Good Clinical Practice (GCP), and compliance with relevant regulations.

• Coordinates and oversees clinical site monitoring tasks for assigned studies in line with contractual obligations, standard operating procedures (SOPs), and applicable regulatory guidelines.

• May conduct on-site and remote visits for site qualification, initiation, interim monitoring, and site closure.

• Acts as the main contact for sites regarding inquiries about study enrollment, execution, and closure issues; collaborates with relevant study team members as necessary.

• Communicates with site investigators and project teams regarding overall site performance, trends, deficiencies, and concerns through both verbal and written channels.

• Assists in study start-up activities, including tracking and performing quality reviews of study documents, and preparing and distributing site activation letters.

• Conducts training related to the study.

• Manages the creation and upkeep of study documents, processes, and systems as designated.

• Ensures the quality and completeness of central and site master files, tracking and maintaining essential study documents, performing quality control reviews, and managing renewals.

• Monitors study site and overall study metrics, including but not limited to enrollment, deviations, adverse events, and trial master file maintenance.

• Participates in internal and external meetings as required.

• Provides job-related progress reports and visit documentation as needed.

• May assist with safety activities, including narrative writing and managing the Clinical Event Committee (CEC) or Data and Safety Monitoring Board (DSMB).

• For international studies: Prepares and coordinates submissions to regulatory bodies.

• May undertake additional activities as assigned.

⛳️ Requirements

• Proficiency in English and the local language, if applicable, is required.

• A higher education degree or equivalent education, training, and experience is necessary.

• A minimum of 2 years of clinical trial experience is preferred.

• Monitoring experience is preferred.

• Ability to work independently once trained.

• Strong verbal and written communication abilities.

• Excellent organizational skills.

• Basic proficiency in computer usage.

• Familiarity with clinical research processes and regulations.

• Certifications like Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification are preferred but not mandatory.

🏝️ Benefits

• Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates.

• While fulfilling the responsibilities of this position, the employee is frequently required to communicate verbally and audibly. The employee often needs to stand, walk, sit, use hands for various tasks, and reach with hands and arms. Occasionally, the employee must lift and/or move up to 25 pounds. Specific vision capabilities required for this role include close vision, depth perception, and the ability to adjust focus.

• Extensive use of a computer keyboard is necessary.