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.
Job Summary:
The Senior Clinical Research Associate will be responsible for aiding the team members with administrative, logistical, and practical issues, including the tracking, collection, distribution and filing study documentation. The position is responsible for tracking and supervising the collection of ongoing study data for the purpose of regular project status reporting as required.
Primary Responsibilities:
- Conduct site monitoring visits (qualification and selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
- Administer protocol, study specific documents and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol while maintaining adherence to applicable regulations and escalate quality issues as appropriate.
- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, diary and survey data and data query generation and resolution. May support start-up phase.
- Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH and local regulatory requirements.
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Act as a mentor for clinical staff including conducting co-monitoring and training sign-off compliance visits
- Collaborate with study team members for project execution support as appropriate.
- May be accountable for supporting development of project subject recruitment plan on a per site basis
- May be accountable for site financial management according to executed clinical trial agreement and manage invoices according to local requirement
Education/Work Experience/Requirements:
- Bachelor's Degree in scientific discipline or health care preferred.
- Requires at least 4 years of year of on-site monitoring experience.
- Equivalent combination of education, training and experience considered.
- ICU Nursing experience
- Prior CRRT, AKI, Sepsis, ECMO, or Critical Care study experience
- Ability to independently manage difficult academic medical center sites
- Strong source data verification experience in complex hospital EMRs
- Demonstrated success enrolling and monitoring in critical care studies
- Have well developed critical thinking skills
- Have high attention to details
- Comfortable engaging with critical care physicians
- Ability to make sound decisions in ambiguous situations
- Have strong issue escalation and risk management skills
- 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 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
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 will 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 to 25lbs (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!
We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.
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.
