Clinical Research Associate II

RQM+ is a MedTech contract research organization providing regulatory, quality, laboratory, clinical trial, and reimbursement services for medical technologies. The Clinical Research Associate II supports pre-market through post-market clinical trials by coordinating site activities, conducting monitoring visits, ensuring regulatory and Good Clinical Practice compliance, reviewing clinical data, and supporting study closeout.

Responsibilities

Collaborates with the start-up department to coordinate activities with assigned sites 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

Assists in resolving any issues to ensure compliance with site file audits in conjunction with eTMF

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

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

Participate in training and mentoring new staff up to Clinical Research Associate level as appropriate

Performs other duties, as requested

Preferred

Bachelor's Degree in scientific discipline or health care preferred

In-house or remote monitoring experience preferred

In-depth 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

Bachelor’s Degree

Healthcare Background

In-House Monitoring

Remote Monitoring

Clinical Research Regulations

Clinical Trial Regulation

Clinical Practice (ICH-GCP)

ISO 14155

MedTech Regulations

MedTech Experience

Benefits

RQM+ invests heavily in ongoing learning and development.

Company

Full-service medtech CRO and regulatory consulting partner

Cary, North Carolina, USA

https://www.rqmplus.com/

Founded in 2008

501-1000 employees

Qualifications

Requires at least 2 years of on-site monitoring experience with medical device clinical trials

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 act in a lead role on a study assuming additional responsibilities as detailed/documented by the Project Manager if appropriate

Bachelor's Degree in scientific discipline or health care preferred

In-house or remote monitoring experience preferred

In-depth 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

Requires at least 2 years of on-site monitoring experience with medical device clinical trials.

Required skills

Medical Device Clinical Trial Monitoring, Clinical Research Regulatory Requirements, Clinical Practice (ICH-GCP), ISO 14155, Therapeutic and Protocol Knowledge, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Relationship Management

Preferred skills

In-house or remote monitoring experience preferred, MedTech regulations and active experience preferred

Experience

2+ years