Clinical Research Associate I

Summary

Join RQM+ as a Clinical Research Associate I (CRA I) and oversee the progress of clinical investigations by conducting site interim monitoring visits. Monitor clinical trials according to Good Clinical Practices and RQM+ and sponsor procedures. Collaborate with the Clinical Trial Manager (CTM) and/or Lead CRA to ensure monitoring activities align with study requirements. Responsibilities include assuring adherence to Good Clinical Practices, performing source documentation validation, documenting product inventory, ensuring return or destruction of unused study product, reviewing clinical data quality, resolving data queries, training site staff, assisting with compliance, serving as primary contact between stakeholders, potentially performing study initiation and close-out activities, attending meetings, and completing required trainings. The role requires a Bachelor's degree in a scientific discipline or healthcare (preferred), monitoring experience (preferred), knowledge of clinical research regulatory requirements, strong therapeutic and protocol knowledge, computer skills, excellent communication skills, organizational abilities, and the ability to travel frequently. The position does not involve supervisory responsibilities.

Requirements

• Bachelor's Degree in scientific discipline or health care preferred
• Equivalent combination of education, training and experience considered
• Strong therapeutic and protocol knowledge as provided in company training
• Computer skills including proficiency in the use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and mobile technology required
• Written and verbal communication skills including command of English language
• Organizational and pragmatic problem-solving skills
• Effective time and financial management skills
• Ability to establish and maintain effective working relationships with coworkers, managers, sponsor staff and sites
• Ability to travel up to 60-75%

Responsibilities

• Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits
• Performs validation of source documentation as required by sponsor and prepares monitoring reports and letters per the timelines defined in RQM+ SOPs by using approved templates and reports
• Documents accountability, stability and storage conditions of investigational and commercial product inventory as required by sponsor
• Ensures return of unused study product to designated location or verifies destruction as required
• Reviews the quality and integrity of the clinical data through in-house review of electronic CRF data and on-site or remote source verification
• Works with sites to resolve data queries
• Trains site staff on the EDC system
• Assists in resolving any issues to ensure compliance with site file audits in conjunction with eTMF
• Serves as primary contact between RQM+, sponsor and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested
• May perform study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and other required topics
• May perform study close-out visits per the study specific Clinical Monitoring Plan including final study product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items
• Attends, Investigator Meetings for assigned studies
• Attends study-related, company, departmental, and external meetings, as required
• Ensures internal and study-related trainings are completed per RQM+ process and/or study timelines, including updating the study level trial management system
• Ensures all study deliverables are completed per RQM+ and study timelines
• Performs other duties, as requested

Preferred Qualifications

• In-house or remote monitoring experience preferred
• Beginner knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Clinical Trial Regulation, Good Clinical Practice (ICH-GCP) guidelines and International standards like ISO 14155. MedTech regulations and active experience preferred