Careers

Since Inception, MCRA, LLC. has been at the forefront of the neuro-musculoskeletal industry. When you work with MCRA, you join the leading advising firm and CRO to the orthopedic technology space. An organization at an exciting juncture - with continued expansion into various other medical/surgical specialties and indications.

Our team thrives in a fast-paced work environment that elicits creativity and advanced problem-solving ability. Our offices offer a collaborative, collegial atmosphere conducive to each person's development and success. Our team members are the heart of the organization's growth and therefore fully invested in. MCRA's unique team is comprised of various backgrounds of knowledgeable and passionate people and we invite you to be a part of our growth.

 

What We Offer You

  • A company with strategic vision and the focus to serve the medical device community.
  • Professional growth through training programs, challenging assignments, and the opportunity to collaborate with great individuals.
  • A supportive, experienced and collegial environment with people who value your experience and skills.

 

Hiring Initiatives

While MCRA is always interested in knowledgeable, energetic, and committed individuals, below is a list of our current needs. Click on any of the jobs below for a description. Please contact us at: careers@mcra.com with any questions or career inquiries.

 

Clinical

  • In-House Clinical Research Associate

    Job Title: In-House Clinical Research Associate

    Location: Washington, DC 

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    JOB SUMMARY

    Responsible for management of investigator site and Clinical Research Associate (CRA) activities for assigned studies. Execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.

    RESPONSIBILITIES:

    • Review regulatory documents required for the implementation of clinical trials.
    • Contribute to protocol-specific manuals, plans, and documents as needed.
    • Ensure that monitoring activities (remote and on-site) are completed in accordance with company/client SOPs and Clinical Monitoring Plan.
    • Conduct on-site and remote study monitoring and site management.
    • Assist project manager with clinical study planning, as required.
    • Develop and maintain positive relationships both internal and external to project, including clients, team members, and site personnel (Pls, Study Coordinators, etc.).
    • Assist in the identification and recruitment of potential investigators and study sites.
    • Assist with site qualification activities.
    • Assist with document collection and review for the Trial Master File throughout the life cycle of the project.
    • Assist with site training for assigned clinical trials.
    • Assist with site audits and site quality management activities as needed.
    • Maintain current knowledge of GCP and FDA guidance as it relates to clinical research, as well as current clinical related developments in the assigned therapeutic areas.

    QUALIFICATIONS

     Required Knowledge, Skills, & Experience

    • Education: Bachelor's degree (B.A./B.S.) in science or RN with clinically related experience.
    • Certification/Licensure: None.
    • Experience: 2+ years of clinical trial experience. Monitoring experience preferred.

    OTHER

    • Knowledge of GCPs and clinical trial procedures.
    • Understanding of therapeutic area for assigned clinical projects.
    • Proficiency with MS Office applications.
    • Experience using Electronic Data Capture (EDC) and clinical trial management systems.
    • Demonstrated professional oral and written communications.
    • Ability to read, write, speak, and understand English.
  • Sr. Clinical Trial Manager

    Job Title: Sr. Clinical Trial Manager

     

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    JOB SUMMARY

    Provide oversight and management for all clinical aspects of the development and execution of clinical trials/protocols. Execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.

    RESPONSIBILITIES:

    • Ensure that clinical studies are properly resourced, managed, and executed in accordance with established timelines and quality standards.
    • Ensure that studies are conducted according to the study protocol, SOPs, ICH/GCP regulations and study-specific manuals ad procedures.
    • Develop and maintain positive relationships both internal and external to project, including clients, team members, and site personnel (Pls, Study Coordinators, etc.).
    • Lead and direct project team to ensure deliverables meet project timelines.
    • Track and report on progress of study including site activation, patient enrollment, and monitoring visits.
    • Develop Clinical Monitoring Plan and other project documents as assigned.
    • Manage clinical monitoring functions of clinical studies.
    • Approve reports and study communications generated by the project team for distribution to sponsors and investigators.
    • Ensure Trial Master File is accurate and complete throughout the life cycle of the project.
    • Oversee study vendors, when applicable.
    • Provide ongoing study training to the clinical project team.
    • Assist with professional development for Clinical Research Associates and Clinical Associates.
    • Maintain knowledge of current GCP, FDA, and other applicable regulations.
    • Other duties as assigned by Senior Director, Clinical Affairs.

    QUALIFICATIONS

    • Required Knowledge, Skills, and Experience
      • Education: Bachelor's degree (B.A. / B.S.) or equivalent in a health sciences field.
      • Certification/Licensure: CCRP or similar certification preferred. PMP or similar management certification preferred.
      • Experience: 3+ years of experience in clinical trials management. 8+ years clinical research industry experience. Experience with Clinical Trial Monitoring. Medical Device experience required.

    OTHER

    • Comprehensive and demonstrated knowledge of coordination and management of projects.
    • Understanding of therapeutic area for assigned clinical projects. 
    • Proficiency with MS Office applications. 
    • Experience using Electronic Data Capture (EDC) and clinical trial management systems for project management and monitoring. 
    • Demonstrated professional oral and written communications.
    • Ability to read, write, speak, and understand English required. 
    • Ability to travel as may be required.

Quality Assurance

  • Sr. Quality Engineer

    Job Title: Sr. Quality Engineer

     

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    JOB SUMMARY

    Candidates must have expert knowledge of 21 CFR Part 820, ISO 13485:2016, ISO 14971:2012, and the EU MDD or MDR. Knowledge of MDSAP, CMDCAS, and TGA is desirable. This position has the potential for growth into a more senior leadership role for the right candidate depending on experience and performance.

    RESPONSIBILITIES

    • Create, review, and improve:
      - Quality systems to meet regulations and standards.
      - DHFs, DMRs, and DHRs.
      - Technical files, design dossiers, ERCs, CERs, and STEDs.
      - FMEAs, DFMEAs, and PFMEAs.
      - Responses to FDA 483s and warning letters.
    • Plan and perform:
      - DHF and DHR remediations.
      - Internal, supplier, and due diligence audits.
      - Mock FDA inspections, including mock Pre-Approval Inspections.
      - Back- and front-room support for inspections and audits.
      - Remediations for Notified Body and Authorized Organization audits.
      - Gap assessments against regulations and standards, including ISO and IEC requirements.
      - Validations for device design, device software, manufacturing processes, and packaging.
      - Validations for quality system software, including for 21 CFR Part 11.
      - Validations for cleaning and sterilization.
    • Support or lead:
      - Design control projects, including design review meetings.
      - Complaint handling and CAPA processing.
      - Medical device/adverse event reporting to FDA, Authorized Representatives, and international regulatory bodies.
      - Corrections, removals, and recalls.
      - Nonconforming material and SCAR activities.
      - Supplier management programs.
      - UDI labeling, marketing, and submission to GUDID.
      - Communications with FDA, Notified Bodies, Authorized Organizations, Authorized Representatives, and          international regulatory bodies.

    QUALIFICATIONS

    • Minimum 7 years QA experience.
    • Minimum of 3 years auditing experience. 
    • Bachelor degree in scientific or related field.
    • Willingness to travel up to 50% (average) of working days.
    • Willingness to work with a variety of US and international clients.
    • Excellent writing skills.
    • Excellent people skills.
    • Detail-oriented, highly organized, independent, and self-motivated.
    • Experience with a variety of device types is desirable,
    • ASQ certification is desirable (CQA, CQE).

Interested in Joining the MCRA Team?

Contact us with questions or any interests you may have that relate to our job openings at careers@mcra.com