Senior Clinical Research Associate – Field Based

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

📋 Description

• Ensure adherence to human subject protection, Good Clinical Practice (GCP), and relevant regulations.

• Oversee and coordinate clinical site monitoring duties for designated studies.

• Conduct both on-site and remote evaluations, including site qualifications, initiations, interim assessments, and close-out monitoring visits.

• Act as the primary contact for sites concerning enrollment, operational conduct, and close-out inquiries.

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

• Assist in study start-up activities, which include document tracking, quality reviews, and site activation letters.

• Deliver study-related training.

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

• Ensure the quality and completeness of central and site master files.

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

• Attend both internal and external meetings, providing progress updates and visit documentation.

• Assist in safety activities, including narrative writing and managing the CEC/DSMB.

• Prepare and manage regulatory authority submissions outside the U.S.

• Evaluate potential investigative sites and contribute to site selection decisions.

• Aid in site budgets and contract negotiations.

• Prepare sites for audits, address audit action items, and support sites during audit processes.

• Participate in meetings with prospective clients.

• Provide training and mentorship to Clinical Research Associates (CRAs).

• Support the Clinical Study Manager with the protocol, investigational plan/brochure, SIV training presentations, and the development of study operations.

• Assist in Core Laboratory management.

• Facilitate data management through CRF development, validation rules, user acceptance testing (UAT), data review, trend analysis, and reporting.

• Conduct and summarize literature searches.

• Register trials on ClinicalTrials.gov.

⛳️ Requirements

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

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

• Ability to work independently after receiving training.

• Strong verbal and written communication abilities.

• Excellent organizational skills.

• Basic proficiency with computers.

• Understanding of clinical research processes and regulatory requirements.

• A minimum of 5 years of clinical trial experience is preferred.

• At least 3 years of monitoring experience is preferred.

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

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

• Up to 80% travel is expected for Field Clinical Research Associates.

• Ability to communicate, hear, stand, walk, sit, use hands for handling, and reach with arms.

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

• Close vision, depth perception, and the ability to adjust focus are required.

• Extensive use of a computer keyboard is necessary.

🏝️ Benefits

• Up to 20% travel is required 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 essential job functions.

• Commitment to equal employment opportunity.

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