Senior Clinical Research Associate

Are you ready for new challenges and new opportunities?

Join our team!

Current job opportunities are posted here as they become available.

RQM+ is The Med Tech 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 Med Tech. We make Med Tech 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 Med Tech 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.

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.

• 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 elevate 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

• 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…