Senior Clinical Research Associate

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

📋 Description

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

• Oversee and coordinate clinical site monitoring duties in line with contractual commitments, Standard Operating Procedures (SOPs), and regulatory standards.

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

• Act as the main point of contact for site inquiries regarding enrollment, study conduct, and close-out matters.

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

• Assist in study start-up tasks, encompassing study document tracking, quality review, and site activation correspondence.

• Deliver training related to the study.

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

• Ensure the quality and completeness of both central and site master files; monitor required documents, conduct quality control reviews, and manage renewals.

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

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

• Assist with safety-related activities, including narrative documentation and management of the Clinical Events Committee/Data Safety Monitoring Board (CEC/DSMB).

• Prepare and coordinate submissions to regulatory bodies outside the U.S.

• Evaluate investigative site suitability and contribute to the site selection process.

• Aid in site budget management and contract negotiations.

• Support sites during audits and in addressing audit action items; facilitate audits both remotely and on-site.

• Engage in meetings with potential clients.

• Assist in the training and mentoring of Clinical Research Associates (CRAs) during both remote and on-site visits.

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

• Aid in managing Core Laboratory activities and serve as the primary contact when designated.

• Support data management tasks, including Case Report Form (CRF) development, validation criteria, User Acceptance Testing (UAT), data review, trend analysis, and reporting.

• Conduct and summarize literature reviews.

• Register clinical trials on Clinicaltrials.gov.

• Undertake other assigned responsibilities.

⛳️ Requirements

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

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

• A minimum of 5 years of experience in clinical trials is preferred.

• At least 3 years of monitoring experience is preferred.

• A minimum of 1 year of experience in device trials is preferred.

• Ability to work independently after receiving training.

• Excellent verbal and written communication skills.

• Strong organizational abilities.

• Basic computer skills are required.

• Familiarity with clinical research processes and regulations is necessary.

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

• Extensive keyboard usage is expected.

• Capability to occasionally lift and/or move up to 25 pounds.

• Must meet the specified physical demands, with reasonable accommodations considered where applicable.

🏝️ 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 allow individuals with disabilities to perform essential functions.

• Equal employment opportunity.

• Pre-employment background checks and drug screening processes in accordance with local, state, and federal laws.