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.

 

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).

Regulatory Affairs

  • Senior Associate, Cardiovascular Regulatory Affairs

    Job Title: Senior Associate, Cardiovascular Regulatory Affairs

     

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    JOB SUMMARY

    The Senior Associate, Cardiovascular Regulatory Affairs will be a critical team member reporting to the Vice President of Cardiovascular Regulatory Affairs, to support regulatory strategy and submissions for the firm's cardiovascular clientele. The majority of projects will initially be based around the following product types: stents, heart valves, circulatory support devices, intravascular catheters, etc., and we expect for this position to develop into supporting additional technology areas (i.e: electrical cardiology devices) and other growing therapeutic concentrations of MCRA.

     

    RESPONSIBILITIES

    • Develop and execute regulatory services for client companies, including but not limited to:
      - Regulatory Strategy, Analysis, & Development
      - US Regulatory Submissions (510(k), IDE, PMA, IND, BLA, & IND)
      - Design, Review, and Implement Pre-Clinical Testing
      - Provide consultation on biological safety risk assessment, testing plans/strategies, test parameters and methods through understanding and implementation of analytical/chemical, in silico, in vitro, and in vivo testing methodologies in accordance with ISO Standards, FDA Guidance, and global regulatory requirements.
    • Work with other department heads and leadership team to guide the progress and development of the cardiovascular division as well as the regulatory department and company as a whole
    • Work collaboratively with other MCRA departments, including Clinical, Reimbursement, and Quality Assurance
    • Other projects

     

    QUALIFICATIONS

    • Bachelor of Science in a scientific discipline (biology, engineering, or a heavily technical writing based curriculum), MS, MSE, or PhD preferred
    • Minimum of 3-5 years of experience in Regulatory Affairs experience related to medical devices
    • The ideal candidate must have significant experience in one or more of the following device areas: Cardiac Diagnostics Devices, Cardiac Electrophysiology Devices, Circulatory Support Devices, Interventional Cardiology Devices, Implantable Electrophysiology Devices, Structural Heart Devices, Vascular Surgery Devices
    • Must have an understanding of mechanical engineering concepts and a biological background to assist with pre-clinical and clinical strategies, and be able to effectively communicate these strategies to internal team members and clients
    • Work experience must include assisting in the writing and/or reviewing of regulatory submissions
    • An understanding of clinical research and data analysis is desired
    • Possesses strong written and verbal communication and presentation skills
    • Strong research, analytical, critical thinking, and problem-solving skills
    • Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently
    • PC/Technical skills - MS Office, Excel, Word, PowerPoint (Endnote experience a plus)
    • Effective interpersonal skills: shows confidence with subject matter and 'calm under pressure' approach and style
    • Strong professionalism and experience working with internal and client relationships at all levels

Clinical Research

  • Senior Regional Clinical Research Associate

    Job Title: Senior Regional Clinical Research Associate

     

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    JOB SUMMARY

    The Senior Clinical Research Associate will be a critical team member reporting directly to the Direct of Clinical Affairs, to support clinical trial operations for the firm's clientele. Responsible for management of investigator sites and Clinical Research Associate (CRA) activities for assigned studies. The Senior CRA will execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.

     

    RESPONSIBILITIES

    • Review research and study regulatory documents required for the implementation, monitoring, and evaluation of clinical trials
    • Design 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 and management, as required
    • Develop and maintain positive relationships both internal and external to projects, including clients, team members, and site personnel (PIs, Study Coordinators, etc.)
    • Verify site qualifications and capabilities to conduct clinical studies
    • Ensure Trial Master File is accurate and complete throughout the lifecycle of the project
    • Prepare and conduct sire and CRA 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
    • Assist with professional development for less-experienced Clinical Research Associates and Clinical Associates, as needed

    NOTE: This job description is not intended to be all inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization

     

    QUALIFICATIONS

    • Bachelor of Science in a scientific discipline, BSN/RN, or similar; MS preferred
    • Minimum of 3-5+ years of clinical trial monitoring experience; Device Monitoring experience highly preferred
    • Comprehensive knowledge/fluency of GCPs and clinical monitoring procedures
    • Understanding of the therapeutic area for assigned clinical projects. Experience in orthopedics and/or cardiovascular is a plus
    • Experience using Electronic Data Capture (EDC) and clinical trial management systems
    • Attention to detail and the ability to work individually within a multi-disciplinary team as well as with extetnal partners and vendors
    • Possesses strong written and verbal communication and presentation skills
    • Proven track record of positive site and PI interactions
    • Strong research, analytical, critical-thinking and problem-solving skills
    • Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently
    • PC/Technical skills - MS Office, Excel, Word, PowerPoint (Endnote experience is a plus)
    • Must be polished and professional
    • Effective interpersonal skills: shows confidence with subject matter and a 'calm under pressure' approach and style
    • Strong professionalism
    • Ability to read, write, speak, and understand English
  • Clinical Data Programmer

    Job Title: Clinical Data Programmer

     

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    RESPONSIBILITIES

    • Programs and validates TLF shells based on study needs in conjunction with biostatistics, clinical affairs, and regulatory affairs teams and populates the same per reporting needs
    • Programs and validates custom programs based on study needs for sponsor, biostatistics, data management, clinical affairs, and regulatory affairs teams. Reports may include, but are not limited to: query aging and status reports, AE reports, PD reports, etc.
    • Works with regulatory affairs and data management to ensure that data extracts and form population for DSMB and CEC meetings are accurate, reproducible and automated where possible
    • Assists in standardization of field naming and coding conventions
    • Develops and executes an SOP on central data cleaning and monitoring for all current and future studies
    • Develops and maintains additional SOPs as needed
    • Identify training for department staff as needed
    • Assist in the development, implementation, and delivery of departmental training programs
    • Interact with other departmental staff to ensure that project and department activities are successfully completed
    • Build and maintain EDC systems for clinical studies as needed
    • Assist with CRO vendor selection, evaluation, and oversight
    • Performs additional tasks as his/her background and expertise identifies as being of value

     

    QUALIFICATIONS

    • Master's degree (M.A./M.S.) or equivalent in Programming/Biostatistics or related field; relevant experience acceptable in lieu of Master's degree.
    • 10 years of experience in clinical research including significant experience in a technical environment using SAS for data management and/or biostatistics
  • Senior Clinical Data Manager (Washington, DC-based)

    Job Title: Senior Clinical Data Manager 

     

     

    Location: Washington, DC

     

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    JOB SUMMARY

    MCRA is currently seeking a Senior Clinical Data Manager to work in our Washington, D.C. office. This position reports to the Associate Director of Data Management. The ideal candidate is forward thinking and self-motivated, and will proactively provide direction, leadership, and hands on support to other clinical data managers and colleagues for all assigned studies to ensure timely and high-quality data deliverables that are scientifically rigorous and accurate.

     

    RESPONSIBILITIES

    • Serve as lead data manager on data for multiple projects as assigned
    • Participate in protocol review focusing on data management needs and interests
    • Oversee day-to-day data management activities from study start-up through final database lock, including but not limited to development and curation of regulated documents, electronic data capture (EDC) set-up and management (including creation of eCRFs, performing UAT, visit map, reports, edit checks, and validation rules), data query management and resolution, and interim data locks and reporting
    • Act as data management liaison between study sponsors and internal groups
    • Draft and curate study related documents including the Data Management Plan, UAT Guide, eCRF Completion Guidelines, and related SOPs
    • Attend software related training and pass knowledge down to data management staff and other members of the study team
    • Follow all data management SOPs and suggest changes to improve department effectiveness as needed
    • Discuss data management topics in meetings for assigned studies
    • Lead scheduled data audits and draft reports of audit findings
    • Maintain proper documentation of data management activities
    • Read technical literature and participate in continuing education or professional associations to maintain awareness of current database technology and best practices
    • Perform other duties as assigned

     

    QUALIFICATIONS

    • Bachelor's degree in related field of study
    • 5+ years as a data manager and/or clinical database programmer or equivalent combination of education and experience in a CRO or related environment
    • Knowledge of Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP) and regulatory requirements related to clinical data management processes, documentation, and software
    • Knowledge and application of CDASH/CDISC a plus
    • Proficiency in Base SAS is preferred
    • Ability to adapt to rapidly changing situations and multiple requests
    • Ability and drive to learn new software and systems both with direction and independently
    • Experience writing and maintaining data management plans, CRF completion guidelines, detailed work instructions, and SOPs
    • Experience with OpenClinica, Medrio, Viedoc or other cloud-based EDC
    • Hands-on experience building studies in cloud-based EDC systems desired
    • Excellent communication, organization, time management, and interpersonal skills
    • Self-starter, able to communicate well within a team environment. Candidate will be proactive in managing and completing tasks in a timely fashion
  • In-House Clinical Research Associate (Washington, DC-based)

    In-House Clinical Research Associate (Washington, DC-based)

     

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    JOB SUMMARY

    The In-House Clinical Research Associate will be a critical team member reporting directly to the Director of Clinical Affairs, to support clinical trial operations for the firm's clientele. Responsible for support of investigator sites and Clinical Research Associate (CRA) activities for assigned studies. The In-House CRA will execute Clinical Affairs functions in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), and any other applicable regulatory requirements.

     

    RESPONSIBILITIES

    • Review and approve research and study regulatory documents required for the implementation, monitoring, and evaluation of clinical trials
    • Review clinical protocols to ensure efficient collection of accurate data required for regulatory submissions 
    • 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
    • Assist Project Manager with clinical study planning and management, 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, as needed
    • Ensure Trial Master File is accurate and complete throughout the lifecycle of the project
    • Assist with site training for assigned clinical trials
    • Assist with site audits and sire 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

    NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

     

    QUALIFICATIONS

    • Bachelor's degree (B,A./B.S.) in pharmacy, pharmaceutics, or a related scientific discipline
    • At least 2 years of clinical trial experience. Monitoring experience preferred
    • Comprehensive knowledge/fluency of GCPs and clinical monitoring procedures
    • Understanding of therapeutic areas for assigned clinical projects
    • Experience using Electronic Data Capture (EDC) and clinical trial management systems
    • Possesses strong written and verbal communication and presentation skills
    • Strong research, analytical, critical-thinking, and problem-solving skills
    • PC/Technical skills - MS Office, Excel, Word, PowerPoint (Endnote experience is a plus)
    • Ability to read, write, speak, and understand English

     

  • Associate, Clinical Quality Assurance (CQA)

    Job Title: Associate, Clinical Quality Assurance (CQA)

     

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    JOB SUMMARY

    Plan, conduct, and report assigned MCRA Clinical Research Organization (CRO) Clinical Quality Assurance (CQA) audits. Support management in the advancement and assessment of compliance to regulations, guidelines, and MCRA standard operating procedures.

    The responsibility of this position is to support the department in the daily upkeep of MCRA's Quality System, including document maintenance, internal audits, vendor qualifications, CAPAs, and training. This individual may serve in the role of Clinical Quality support, providing quality oversight of MCRA activities in support of Clinical Trials. This individual may also be required to provide support in the development and administration of Client Quality Systems.

     

    RESPONSIBILITIES

    • Plan, conduct, and report audits of processes, systems, projects, vendors and/or sites within budget and established timelines.
    • Assist in the facilitation of regulatory inspections and customer audits
    • Review and approve corrective and preventative (CAPA) action plans
    • Promote the concept of quality, the principles of quality management and devise and implement quality improvements
    • Represent CQA on project-related activites
    • Act as a resource on all aspects of GCP and related guidelines and regulations
    • Oversee and participate in the documentation, reporting, and closure of quality issues and SOP deviations
    • Track, organize, and deliver training to other departments concerning MCRA's Quality Management System
    • Provide information, metrics, and trend analysis to assigned project and operational units on the quality of procedures, practices, projects, and systems
    • Ensure the follow-up of major and critical audit findings to confirm that appropriate actions have been taken and have adequately resolved the issues identified
    • Maintain an excellent knowledge of current GCP regulations, guidelines, and related auditing techniques appropriate to work responsibilities
    • Provide regular feedback to Quality Management on the above activities
    • Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures
    • Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
    • Serve as author of Quality Assurance SOPs as assigned.

     

    QUALIFICATIONS

    • Bachelor's degree in Life Sciences or Nursing
    • Minimum 2-3 years' experience in pharmaceutical or device research, including GCP and/or Quality Assurance experience; or equivalent combination of education, training, and experience
    • Knowledge of word-processing, spreadsheet, and database applications
    • Considerable knowledge of GCP regulations/guidelines and quality assurance auditing techniques
    • Strong interpersonal skills
    • Effective organization, communication, and team orientation skills
    • Ability to initiate assigned tasks and to work independently 
    • Ability to manage multiple projects
    • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

     

Reimbursement

  • Coding Hotline Specialist

    Job Title: Coding Hotline Specialist (Manchester, CT-based)

     

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    JOB SUMMARY

    The Patient Access Program (PAP) Coding Hotline Specialist will work with physicians, hospitals, study coordinators, insurance carriers, medical technology manufacturers, and other stakeholders to provide coding information for healthcare services, procedures, and technologies. Working under the direct supervision of the Director of the Patient Access Program, the Coding Hotline Specialist must become well-versed in Medicare billing guidelines and other coding guidelines affecting inpatient and outpatient procedures for facility and physician customers, DME, and diagnostic services.

    The Coding Hotline Specialist's primary responsibility is to monitor and respond to coding and reimbursement hotlines calls. They provide pre-approved and compliant coding and payment information to callers. Depending upon program assignments, the Coding Hotline Specialist may also contact health insurance plans to obtain prior authorization or appeal denied claims for procedures. Coding specialist may be required to participate in coding analyses and complete quality research as may be required.

    Through MCRA supported training and continuing education, Coding Hotline Specialists are required to maintain general coding expertise and develop coding expertise within disease states and specialties associated with client hotlines.

     

    RESPONSIBILITIES 

    • Support Patient Access Program's coding hotline functions by responding positively and proactively to stakeholder telephone calls and electronic communications
    • Perform Patient Access Program administrative functions, including collecting new case information, monitoring efaxes, and entering case information into the proprietary CRM
    • Support the Coverage Access Team and clients/customers with insurance pre-authorizations, appeals, and claim denials in an efficient and timely manner
    • Assist with monthly Client Reporting & Dashboards utilizing a proprietary CRM
    • Adhere to the department's standards for compliance and HIPAA policies
    • Perform Benefits Verification
    • Review Business Associate Agreements (BAA) for completeness and add to internal systems
    • Review literature and summarize for inclusion in pre authorization and appeal letters
    • Draft communications necessary to provide education, write insurance appeals and related messaging on behalf of physicians, hospitals, and patients to secure insurance coverage for innovative technologies

     

    QUALIFICATIONS

    • Certified coder accreditation, Strong candidates with a CPC-A designation will be considered for this position
    • Strong preference given to coding professionals with professional experience or education training in the areas of orthopedics, neurosurgery, and/or cardiovascular
    • College degree or equivalent practical experience
    • Self-directed individual able to manage multiple client hotlines with minimal supervision
    • 3+ years of experience in healthcare at a medical practice, hospital, ambulatory surgical center, or healthcare insurance company
    • Strong understanding of Utilization Review and patient medical appeals
    • Excellent customer service skills
    • Strong verbal communication

     

    SPECIAL REQUIREMENTS

    • Alternative working hours may be required for this position

Administrative

  • Associate, Talent Management

    Job Title: Associate, Talent Management

     

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    JOB SUMMARY

    The Associate, Talent Management will act as a vital member of the MCRA People Operations team. This position will assist with all processes related to talent acquisition and talent management, and will have exposure to the Company's business operations and HR functions.

     

     

    RESPONSIBILITIES

    • Work with internal hiring managers to create and update job descriptions as needed
    • Post job requisitions on the Company website and various external sites (including: LinkedIn, Indeed, ZipRecruiter, university career services, professional associations, and other position-specific job boards as needed)
    • Assist with the updating the Company's Applicant Tracking System (ATS) including initial data migration following implementation
    • Assist with sourcing appropriate candidates through internal and external networks, industry events, career fairs and information sessions, and online electronic resources; keeping an active pipeline of qualified candidates
    • Manage applications to the Company's career page and career email address; ensuring all data and resumes are entered and stored in the ATS
    • Conduct initial resume reviews and phone screens
    • Manage arrangements for candidate interviews:
      - Establish interviewer and candidate availability
      - Schedule meetings in Outlook
      - Provide logistical support for onsite meetings
      - Coordinate travel arrangements where necessary
    • Assist with communications between candidates and hiring managers to ensure optimal timing of the recruitment process
    • Coordinate administrative functions relating to talent
    • Create candidate's New Hire Summary for HR onboarding
    • Work with HR and Administrative Assistant for new hire onboarding, including the ordering and setup of office supplies
    • Collect recruitment updates and data of interest for analysis by the Head of Talent
    • Assist the Head of Talent with ongoing projects as needed

     

     

    QUALIFICATIONS

    • Bachelor's degree or equivalent practical experience
    • 1+ year(s) experience in an office or professional setting
    • Excellent organizational skills and ability to manage changing priorities without missing deadlines
    • Strong written and oral communication skills with the ability to communicate effectively in meetings, via email and in formal discussions
    • Ability to learn and use new tools to collaborate and communicate more effectively
    • Strong Microsoft office skills, especially Outlook, Excel, and PowerPoint
    • Must be willing to travel up to 20% year round, with increasing intensity in the fall season for university events and conferences

    The ideal candidate will be a driven, detail-oriented team player with a positive attitude that is interested in starting/furthering a career in talent management, talent acquisition, HR, organizational development and/or business operations

     

     

    WORK HOURS

    Full Time position. Standard Business Hours. Washington, D.C. based.

    NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization