Senior Clinical Research Associate

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

📋 Description

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

• Oversees and coordinates clinical site monitoring duties for assigned studies in line with contractual agreements, standard operating procedures (SOPs), and applicable regulatory guidelines.

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

• Acts as the main liaison for site inquiries regarding study enrollment, execution, and closure issues, coordinating with relevant study team members as necessary.

• Communicates both verbally and in writing with site investigators and project teams about overall site performance, trends, deficiencies, and concerns.

• Aids in study start-up activities, including tracking and conducting 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 assigned.

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

• Monitors study site and overall study metrics such as enrollment, deviations, adverse events, and trial master file maintenance.

• Participates in both internal and external meetings as required.

• Provides necessary job-related progress reports and documentation of visits.

• May assist with safety-related activities such as narrative writing and managing the Clinical Events Committee/Data Safety Monitoring Board (CEC/DSMB).

• For studies outside of the U.S. (OUS): Prepares and coordinates submissions to regulatory authorities.

• May undertake other assigned activities.

• Evaluates the suitability of potential investigative sites through screening interviews, regulatory document reviews, and assessment of study information, contributing to the site selection process.

• Aids in coordinating site budget and contract negotiations as directed by project leads.

• Assists in preparing sites for audits and resolving any audit-related action items.

• Supports sites during audits, either remotely or on-site as necessary.

• Engages in discussions with prospective clients.

• Facilitates training and mentoring of Clinical Research Associates (CRAs) during remote and on-site visits.

• Manages the creation and/or maintenance of study monitoring plans, templates, trackers, study tools, and site-specific documents.

• Assists the Clinical Study Manager (CSM) with the development of human clinical protocols, investigational plans/brochures, site initiation visit (SIV) training presentations, and study operations development.

• Supports Core Laboratory management and may act as the primary contact.

• Aids data management in the development of Case Report Forms (CRF), validation rules, user acceptance testing (UAT), data review, trend identification, and other reporting/analysis tasks.

• Conducts and summarizes literature searches.

• Registers trials on ClinicalTrials.gov.

⛳️ Requirements

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

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

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

• At least 3 years of monitoring experience is preferred.

• Preferred 1 year of experience in device trials.

• Ability to work independently once trained.

• Strong verbal and written communication skills are essential.

• Excellent organizational skills are necessary.

• Basic proficiency in computer usage is required.

• Understanding of clinical research processes and regulations is important.

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

🏝️ Benefits

• 401(k) matching

• Flexible work hours

• Paid time off

• Health insurance

• Professional development opportunities