Senior Clinical Research Associate

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

📋 Description

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

• Oversee and coordinate responsibilities related to clinical site monitoring.

• Conduct both on-site and remote qualifications, site initiation, interim monitoring, and close-out visits.

• Act as the primary contact for site inquiries and collaborate with study team members.

• Relay site performance, trends, deficiencies, and concerns to investigators and project teams.

• Assist with study start-up tasks, which include tracking study documents and performing quality reviews.

• Conduct training related to the study.

• Manage study documents, processes, systems, monitoring plans, templates, trackers, tools, and site-specific documentation.

• Ensure the quality and completeness of both central and site master files; oversee document tracking and renewals.

• Monitor site and study metrics, including enrollment figures, deviations, adverse events, and trial master file upkeep.

• Participate in internal and external meetings, providing updates and visit documentation.

• Aid in safety activities, including narrative writing and management of the Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB).

• Prepare and manage submissions to regulatory authorities for studies conducted outside the United States.

• Evaluate potential investigative sites and contribute to site selection.

• Support the development of site budgets and assist in contract negotiations.

• Prepare sites for audits, address audit action items, and support audits both remotely and onsite.

• Engage in prospective client meetings.

• Facilitate the training and mentoring of Clinical Research Associates (CRAs) during both remote and onsite visits.

• Assist the Clinical Study Manager with clinical protocols, investigational plans/brochures, Site Initiation Visit (SIV) training presentations, and the development of study operations.

• Assist with Core Laboratory management and data management activities, including Case Report Form (CRF) development, validation rules, User Acceptance Testing (UAT), data review, trend identification, and reporting/analysis.

• Conduct and summarize literature reviews.

• Register trials on ClinicalTrials.gov.

• Perform other assigned tasks.

⛳️ 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 5 years of clinical trial experience is preferred.

• A minimum of 3 years of monitoring experience is preferred.

• At least 1 year of experience in device trials is preferred.

• Ability to work independently after receiving training.

• Strong verbal and written communication skills are essential.

• Excellent organizational abilities are required.

• Basic proficiency in computer skills is necessary.

• A solid understanding of clinical research processes and regulations is essential.

• SoCRA or ACRP certification is preferred but not mandatory.

• Up to 20% travel is expected for In-House Clinical Research Associates, and up to 80% travel for Field Clinical Research Associates.

• Must be able to meet the physical demands of the role, including occasional lifting or moving of up to 25 pounds.

• Extensive use of a computer keyboard is required.

🏝️ Benefits

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

• Reasonable accommodations may be provided to enable individuals with disabilities to perform the essential functions of this job.