Clinical Trial Associate

Job Summary

The Clinical Trial Associate supports the Clinical Trials team(s) in the overall management and administration of trials, including planning, execution, and closeout of one or more clinical trials in a fast-paced environment. The primary responsibility is to independently manage clinical study tasks on behalf of the team in compliance with protocols, SOPs, GCP and applicable regulatory requirements.

Primary Responsibilities

• Provides support to the Clinical Project Manager and all Functional Management, including:
• Creating and maintaining internal files for consistent organization of documents
• Scheduling and managing attendance for project (internal and external) and functional team meetings, as requested
• Generating meeting agendas and taking minutes from meetings
• Support for binders
• Support the day-to-day tasks of the Clinical Trial team(s), including monitoring visit preparation, tracking of study document collection by site or by topic
• Aid in study start-up activities
• Maintain audit ready filing in the (electronic) Trial Master File (eTMF)
• Complete routine QC checks of eTMF and corrects discrepancies
• Aid in the creation and distribution of Investigator Site Files as needed
• Support CRA with site monitoring visit preparation
• Aid in the creation and submission of regulatory documents as needed
• Aid in the preparation of reports and/or requests as required
• Responsible for tracking and maintaining site status, milestones, and deliverables
• Support departmental initiatives and process improvements

Minimal Travel Required

(10% both international and domestic)

Education/Work Experience

• B.S./B.A. degree is preferred
• Science/health care related field preferred but not required
• Minimum 1 year of professional experience or equivalent is preferred
• Prior experience in the biotech, pharmaceutical, or medical device industry is preferred

Behaviors

• Action-Oriented
• Approachability
• Building Effective Teams
• Business Acumen
• Career Ambition
• Composure
• Courage (Managerial)
• Customer Focus
• Decision Quality
• Informing
• Integrity & Trust
• Interpersonal Savvy
• Planning

Requirements

• Ability to organize and manage multiple priorities and/or projects
• Ability to manage time, plan, and organize effectively
• Strong written and verbal communication skills
• Attention to detail and thorough follow-up skills
• Participate in coordination of clinical trial related activities
• Maintenance and management of study/program trackers
• Knowledge of ICH/GCP/local regulations
• Effectively and efficiently interact with internal and external personnel

Supervisory Responsibilities

This position does not have supervisory responsibilities.

Work Environment/Physical Demands

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds.

Company Information

RQM+ is The MedTech CRO, accelerating innovation to patient impact. Our tailored solutions deliver regulatory and quality expertise, FDA-recognized laboratory services, clinical trials, and reimbursement strategies across device types and therapeutic areas to bring life-changing technologies to patients — faster, safer, better. We don’t make MedTech. We make MedTech happen. Our experienced teams are cohesive, collaborative, and proactive, constantly seeking to improve and evolve while remaining laser-focused on customer success. RQM+ elevates the MedTech experience through best-in-class service and clear, concise communication. We serve as an extension of our customers establishing and maintaining excellent client and site relationships and providing direct access to our technology platforms for real-time data and study transparency.