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Clinical Research Associate - East Coast

Remote: 
Full Remote
Contract: 
Full time
Work from: 
United States

Offer summary

Qualifications:

Bachelor's Degree in a scientific discipline or healthcare preferred., At least 2 years of on-site monitoring experience required., In-depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines., Strong computer skills, including proficiency in Microsoft Office and effective communication skills. .

Key responsabilities:

  • Participates in investigator recruitment and site qualification visits for clinical studies.
  • Monitors clinical trials to ensure compliance with study protocols and regulatory requirements.
  • Serves as the primary contact between RQM+, sponsors, and investigators, coordinating all correspondence.
  • Performs study close-out visits and ensures all study deliverables are completed on time.

RQM+ logo
RQM+ SME https://www.rqmplus.com/
501 - 1000 Employees
See all jobs

Job description

RQM+ is the leading MedTech solutions partner, accelerating the product lifecycle from innovation to patient impact. While manufacturers create medical technology, we apply our end-to-end expertise to propel products from concept through market entry and ongoing post-market support.

Our tailored solutions bring unmatched regulatory and quality expertise, FDA-recognized laboratory and materials science, comprehensive clinical trial design and execution, and impactful reimbursement strategies — accelerating market entry and commercial growth. We partner closely with manufacturers across device types and therapeutic areas to deliver life-changing technologies to patients: faster, safer, better.

We don’t make MedTech. We make MedTech happen.

RQM+ clinical trial services maintains the highest level of integrity and brings unique value to MedTech manufacturers. 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

The Clinical Research Associate (CRA) 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, and interim 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:
  • 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 in conjunction with ISS.
  • 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.
  • 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.
  • Ability to travel up to 50%

    • 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 Demands:
  • This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers and filing cabinets. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 10 pounds and occasionally lift or move objects up to 25 pounds.
    • 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.

    Required profile

    Experience

    Spoken language(s):
    English
    Check out the description to know which languages are mandatory.

    Hard Skills

    Good Clinical Practices (GCP)Regulatory ComplianceClinical ResearchContinuous MonitoringData ValidationProject CoordinationElectronic Data Capture (EDC)Clinical Trial Management SystemsInternal DocumentationFDA Regulations

    Other Skills

    • Training And Development
    • Communication
    • Time Management
    • Organizational Skills
    • Social Skills
    • Problem Solving
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