Senior Clinical Research Associate - Medical Device

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

📋 Description

• Oversee and coordinate clinical monitoring and site management tasks.

• Perform remote and on-site visits to evaluate adherence to protocols and regulatory requirements.

• Manage essential clinical trial documentation and adhere to sponsor procedures.

• Ensure that trials conform to approved protocols, ICH-GCP standards, relevant regulations, and SOPs.

• Maintain audit readiness and foster collaborative relationships with investigational sites.

• Monitor investigator sites utilizing risk-based monitoring, root cause analysis, and corrective/preventive measures.

• Ensure the accuracy of data through source data review, source data verification, and case report form evaluation.

• Evaluate investigational product inventory and maintain accurate records.

• Document findings in reports and correspondence, escalating issues until resolution.

• Maintain ongoing communication with investigative sites between monitoring visits.

• Track trial progress and provide updates to the Clinical Team Manager.

• Update and perform quality checks on clinical trial management systems.

• Participate in investigator meetings and identify potential investigators.

• Initiate clinical trial sites and assist with trial closeout and material retrieval.

• Ensure completeness of essential documents and conduct on-site file audits.

• Assist with project publications, tools, trip report assessments, newsletters, and CRA team calls.

• Promote communication among investigative sites, the client company, and the project team.

• Address company, client, and regulatory needs, including audits and inspections.

• Complete expense reports, timesheets, and other administrative duties.

• Contribute to project initiatives and process enhancement efforts.

⛳️ Requirements

• Bachelor's degree in a life sciences field or a Registered Nursing certification, or equivalent relevant academic or vocational qualification.

• A minimum of 2 years of experience as a clinical research monitor.

• Valid driver's license where applicable.

• Consideration of equivalency through a combination of relevant education, training, and/or directly related experience is possible.

• Strong clinical monitoring skills.

• Knowledge of medical/therapeutic areas and medical terminology.

• Understanding and application of ICH GCPs, relevant regulations, and procedural documents.

• Critical thinking, root cause analysis, and problem-solving abilities.

• Capability to manage Risk-Based Monitoring concepts and processes.

• Strong oral and written communication skills, including interaction with medical personnel.

• Customer-focused, with good listening skills and attention to detail.

• Strong interpersonal, organizational, and time management abilities.

• Flexibility and adaptability are essential.

• Ability to work independently or collaboratively within a team.

• Proficient in Microsoft Office and capable of learning relevant software.

• Good command of the English language and grammar.

• Strong presentation skills.

• Ability to meet sponsor/client/site requirements, which may include vaccination status or personal information disclosures.

• Competence in using required personal protective equipment.

• Willingness to travel frequently, generally 60-80%, including possible extended overnight stays.

🏝️ Benefits

• Frequent travel, typically 60-80%, with increased travel for some individuals.

• Flexible remote work arrangement, involving both remote and on-site monitoring activities.

• Standard work schedule from Monday to Friday.