Senior Clinical Research Associate

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

📋 Description

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

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

• May carry out on-site and remote site qualification, initiation, interim monitoring, and close-out visits.

• Acts as the main point of contact for site inquiries regarding study enrollment, execution, and close-out issues, collaborating with relevant study team members as necessary.

• Engages in both verbal and written communication with site investigators and project teams regarding overall site performance, trends, deficiencies, and concerns.

• Aids in study start-up activities, including tracking and performing quality reviews of study documents, issuing site activation letters, and more.

• 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, tracks necessary study documents, performs quality control reviews, and oversees 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 progress reports and visit documentation related to job responsibilities as needed.

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

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

• May undertake additional tasks as assigned.

• Evaluates the suitability of potential investigative sites through screening interviews, review of regulatory documents, 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 in addressing audit action items.

• Provides support to sites during audits, whether remotely or onsite as necessary.

• Participates in discussions with prospective clients.

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

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

• Assists the Clinical Study Manager (CSM) in developing human clinical protocols, investigational plans/brochures, Site Initiation Visit (SIV) training presentations, and study operations development.

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

• Assists with data management tasks, including the development of case report forms (CRFs), validation rules, user acceptance testing (UAT), data review, trend identification, and other reporting/analysis activities.

• Conducts and summarizes literature searches.

• Registers clinical trials on Clinicaltrials.gov.

⛳️ Requirements

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

• Higher education degree or equivalent education, training, and experience.

• Preferred 5 years of clinical trial experience.

• Preferred 3 years of monitoring experience.

• Preferred 1 year of experience in device trials.

• Ability to work independently after training.

• Strong verbal and written communication skills.

• Excellent organizational abilities.

• Basic proficiency in computer usage.

• Understanding of clinical research processes and regulations.

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

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options