Responsibilities:

• Participates in the investigator recruitment process and performs site qualification visits of potential investigators.
• Evaluates the capability of the site to successfully manage and conduct the clinical study.
• Collaborates with the start-up department to coordinate activities with the site in preparation for the initiation of the study.
• Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.
• Works with start-up, project team and site staff to obtain regulatory (IRB/IEC) approval of study specific documents.
• Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF, monitoring activities and study close-out activities.
• Trains site staff on the EDC system and verifies site computer system.
• Assists in resolving any issues to ensure compliance with site file audits.
• 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 clinical trial materials as required by sponsor.
• Performs investigational or commercial product inventory and accountability (as applicable).
• 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 source verification.
• Works with sites to resolve data queries.
• May review protocols, eCRFs, study manuals and other related documents, as requested by the Clinical Trial Manager and/or Lead CRA.
• 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.
• Performs 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.
• Assists with, and attends, Investigator Meetings for assigned studies.
• Authorized to request site audits due to data integrity concerns.
• 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.
• Serves as mentor for junior staff and those new to the company and/or study.
• Performs other duties, as requested.

Requirements:

• Bachelor’s Degree in scientific discipline or health care preferred.
• Requires at least 2 years of year of on-site monitoring experience.
• Premarket experience.
• IDE experience preferred.
• 2-3 years in-house or remote monitoring experience.
• Equivalent combination of education, training and experience considered.
• In-depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. 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.
• 50% travel may be required including international travel as dictated by study assignment.