Clinical Research Associate II
Rqmplus
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Job summary
RQM+ in Chicago, IL, seeks a Clinical Research Associate II to monitor medical device trials, coordinate site activities, and ensure regulatory compliance across studies.
You will collaborate with sponsors and teams, train site staff on data capture systems, and travel up to 60-75% to sites.
This role emphasizes teamwork, integrity, and delivering high-quality data in a fast-paced MedTech environment.
Qualifications
- Bachelor's Degree in scientific discipline or health care preferred.
- Requires at least 2 years of on-site monitoring experience with medical device clinical trials.
- Proficiency with Microsoft Word, Excel and PowerPoint.
- Ability to travel up to 60-75%.
- Strong knowledge of ICH-GCP and ISO 14155 standards.
Responsibilities
- Coordinate site start-up activities with assigned sites.
- Obtain regulatory documents for monitoring and evaluation.
- Train site staff on the EDC system.
- Ensure compliance with Good Clinical Practices during monitoring.
- Prepare monitoring reports and site communications.
- Perform study close-out visits and data query resolution.
Skills
Education
Tools
Job description
At RQM+, we know the success of our company and the success of our employees go hand in hand. That’s why we offer a compelling employee experience and are committed to helping yoube your best.
Find your next purpose-driven career move.
We take pride in fostering a rewarding culture by…
Supporting and encouraging one another personally and professionally.
Providing ethical and business-balanced solutions to our clients.
Improving lives through the work that we do and efforts in our communities.
Focusing on process and structure internally and for our clients, while being adaptable to individual business needs.
Nurturing a highly skilled, optimistic and passionate team of professionals.
Establishing a welcoming and inclusive environment.
At RQM+, our core values shape how we work, collaborate, and contribute to the success of our clients — and ultimately, to improving patients’ lives.
“The caliber of people who work here is amazing.We have so many smart, kind, decent, and caring people, and that is so nice. From the minute I started, I felt sowelcomed and included. Great job on making sure you hire team players, people willing to collaborate and compromise and be just overall kind and decent people.”
“We get to work on projects that directly affect patients. I feel grateful that I can work with Tier 1 companies and see the product I’ve worked on ‘in the wild.’ I appreciate that my scientific training and experience are so well-suited to my work here and appreciated by clients.”
“I would recommend working at RQM+ becauseyou work with arange of clients, helping them achieve compliance. You help ensure safe and effective medical devices are placed on the market.”
“The work/life balance is unmatchedand the ability to network with such a breadth of expertise and experience is an incredible asset.”
“It’s acaring and balanced culturethat is remains driven to achieve greatness which gives confidence in the company and growth opportunities.”
“I would recommend working at RQM+ because thework/life balance is unmatchedand the ability to network with such a breadth of expertise and experience is an incredible asset.”
“I find meaningin working with my team to find technical solutions that help our clients and promote safe and effective medical devices. Great team.”
“I cannot get over howkind and intelligent everyone is. I feel safe and heard every time I speak. I love the work life balance I have here.”
“The caliber of people who work here is amazing.We have so many smart, kind, decent, and caring people, and that is so nice. From the minute I started, I felt sowelcomed and included. Great job on making sure you hire team players, people willing to collaborate and compromise and be just overall kind and decent people.”
“We get to work on projects that directly affect patients. I feel grateful that I can work with Tier 1 companies and see the product I’ve worked on ‘in the wild.’ I appreciate that my scientific training and experience are so well-suited to my work here and appreciated by clients.”
“I would recommend working at RQM+ becauseyou work with arange of clients, helping them achieve compliance. You help ensure safe and effective medical devices are placed on the market.”
“The work/life balance is unmatchedand the ability to network with such a breadth of expertise and experience is an incredible asset.”
“It’s acaring and balanced culturethat is remains driven to achieve greatness which gives confidence in the company and growth opportunities.”
“I would recommend working at RQM+ because thework/life balance is unmatchedand the ability to network with such a breadth of expertise and experience is an incredible asset.”
“I find meaningin working with my team to find technical solutions that help our clients and promote safe and efficient medical devices. Great team.”
“I cannot get over howkind and intelligent everyone is. I feel safe and heard every time I speak. I love the work life balance I have here.”
At RQM+ we promote equity for all by empowering our people to participate, learn, and excel. We embrace our individual talents and harness them to a common purpose. Together, we strive to create and sustain an inclusive and equitable environment where all employees feel a sense of belonging, respect, and acceptance. We create a culture that attracts and retains brilliant talents of all backgrounds and cultures while advancing global healthcare through MedTech innovation. Collectively, we help bring innovative, safe, and effective medical technology to the patients who need it most within the global communities we serve.
Working at RQM+ isn’t just a job—it’s a chance to make a real impact. Here, your career is more than a path forward; it’s a platform for growth, innovation, and purpose. Explore our open positions and discover how your next move can help shape the future of MedTech. Find purpose in every step.
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.
Hiring Timeline: We are beginning the interview process now with an anticipated start date of November 2026. Timing is subject to change based on business needs.
Location: Looking for candidates in Chicago, IL, TX or NY
Job Summary:
The Clinical Research Associate II (CRA II) participates in the preparation and execution of pre-market to post market clinical trials. Oversees the progress of clinical investigations by conducting site qualification, initiation, interim and close out 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:
- 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
Education/Work Experience/Requirements:
- Bachelor's Degree in scientific discipline or health care preferred.
- Requires at least 2 years of on-site monitoring experience with medical device clinical trials.
- In-house or remote monitoring experience preferred.
- Equivalent combination of education, training and experience considered
- 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.
- 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
- Ability to travel up to 60-75%
Behaviors: Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning
Supervisory Responsibilities: This position does not have supervisory responsibilities.
Work Environment & Physical Requirements:
This role involves regular travel to client and partner sites, which may include varying office and facility environments. The employee should be able to travel independently, navigate different facility types, and occasionally lift or carry items up t0 25 lbs (e.g., equipment, materials, luggage).
These requirements reflect what's typically needed to perform the core functions of this role. If you require an accommodation to perform any aspect of this position, please let us know — we're happy to discuss options.
Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals. At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today!
Job Opportunity Verification:
At RQM+, we prioritize the security of our job applicants. To ensure a safe application process:
- All legitimate RQM+ job opportunities are listed on our official careers page: rqmplus.com/careers
- Every candidate going through the interview process will participate in a voice and/or video interview.
- Exercise caution with unsolicited job offers or requests for sensitive information.
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