Job description
The Clinical Research Associate I (CRA I) primarily oversees the progress of clinical investigations by conducting site interim monitoring visits to clinical sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by RQM+ and sponsors. Works closely with the Clinical Trial Manager (CTM) and/or Lead CRA to ensure all monitoring activities are conducted according to study requirements.
Primary 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
Requirements:
- Bachelor’s Degree in scientific discipline or health care preferred.
- In-house or remote monitoring experience preferred.
- Equivalent combination of education, training and experience considered
- 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.
- 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%
Behaviors:
- Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning
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.
