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

  • Director, Clinical Affairs

    Job Title: Director, Clinical Affairs

    Location: Washington, DC 

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    JOB SUMMARY

    The role of the Clinical Operations Director is to provide leadership for clinical trial activities. Support executive management with business planning and execution of CRO objectives. Support the expansion of CRO operations and expertise. Provide oversight and management for all 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.

    QUALIFICATIONS

    • Required Knowledge, Skills, & Experience
    • BA/BS of equivalent degree in scientific discipline. Advance degree preferred (MA/MS, PharmD, PhD).
    • Minimum 7-8 years of clinical trial experience in a pharmaceutical, biotechnology, CRO and/or healthcare setting with 3+ years of supervisory experience.
    • Experience/knowledge as a project manager in medical device studies is a plus.
    • Previous trial management experience to include:
      • Responsibility for the management and execution of the clinical project.
      • Execution of the Monitoring Plan in consultation with the cross-functional project team, clients and the clinical team. 
      • Presentation of project plans, ongoing updates and project results to management.
      • Oversight of clinical projects to ensure safety concerns and/or adverse events of trends in Safety Reporting are identified and appropriate responses are developed and executed. 
    • Certified Clinical Research Professional (SoCRA or ACRP) preferred.
    • Experience using Electronic Data Capture (EDC) and clinical trial management systems for project management and monitoring.
    • Knowledge of current industry trends at FDA, and what is on the market. 
    • Understanding of medical terminology and confidence when speaking with investigators and medical staff.
    • Excellent organizational skills and attention to detail.
    • Excellent written, verbal, and presentation skills. 
    • Computer literacy, proficiency in MS Office, Excel, PowerPoint, etc.
    • Strong leadership skills; self-starter, good listening skills.
    • Ability to analyze multiple inputs and variables and make decisions.
    • Ability to work on 3-5 protocols at any given time.
    • Ability to travel 10-20%
  • Clinical Project Manager

    Job Title: Clinical Project Manager

    Location: Washington, DC

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    JOB SUMMARY

    The Clinical Project Manager will provide oversight and management for all clinical aspects of the development and execution of clinical trials/protocols. Ensure that clinical studies are properly resourced, managed and executed in accordance with established timelines and quality standards, manage clinical monitoring functions of clinical studies and more are assigned. 

    QUALIFICATIONS

    • Required Knowledge, Skills, and Experience
      • Education: Bachelor's degree (B.A. / B.S.) or equivalent in a health sciences field.
      • Certification/Licensure: None.
      • Experience: 2 years of experience in clinical trials management or related field and 2 years supervisory experience in clinical research environment. 5+ years clinical research industry experience.

    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. 

Quality Assurance

  • Director, Quality Assurance and Manufacturing

    Job Title: Director, Quality Assurance and Manufacturing

    Location: Washington, DC

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    JOB SUMMARY

    Responsible for quality assurance and regulatory compliance for medical device and drug technologies. Mus be able to develop and work within quality systems compliant with FDA QSR and ISO 13485 in the U.S. and European operations. Candidates must also be knowledgeable of the Medical Device Directive (MDD), the new European Medical Device Regulation, the Canadian Medical Device Conformity Assessment System, the Medical Device Single Audit Program (MDSAP) and other applicable regulatory agencies, and other applicable regulatory requirements. This position has the potential for future growth, based on experience, to advance to a senior leadership role for the company's growing Quality Assurance division.

    QUALIFICATIONS

    • Minimum 10 years QA experience
    • Minimum of 3 year QA experience working at the U.S. Food and Drug Administration
    • CQE certified
    • Minimum of 3 years auditing/inspection experience
    • Bachelor degree in scientific or related field
    • Requires strong knowledge of FDA QSR, MDD and ISO 13485:2016 requirements
    • Management experience required
    • Proven leader with excellent writing, team building and communication skills
    • Experience in orthopedic industry desirable
    • Must be willing to travel frequently
    • Excellent writing skills
    • Detail oriented

Reimbursement

  • Sr. Associate/Manager of Contracts and Budgets

    Job Title: Sr. Associate/Manager of Contracts and Budgets

    Location: Washington, DC  - or -  Manchester, CT

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    JOB SUMMARY

    The Contract & Budget Sr. Associate/Manager will work with the study sponsor, physicians, hospitals, legal counsel and MCRA clinical team to draft, develop and negotiate clinical trial agreements and clinical research budgets on behalf of the sponsor client. Collaboration with sponsor management and legal teams to finalize contracts and budgets for clinical research on a daily basis across multiple studies of varying design, scope and therapeutic area. Extensive experience interacting effectively and efficiently with investigators, counsel, executive leadership, and cross-functional teams is a must. The position will report to the Director of Health Economics, Reimbursement & Public Policy and will work closely with the Director of Clinical Affairs and the Vice President of Healthcare Compliance.

    QUALIFICATIONS

    • J.D. required.
    • 2-5 years' experience managing and negotiating clinical trial contracts and budgets at either the sponsor, CRO, or provider (physician, practice, hospital or academic university) level.
    • Ability to read, analyze, and interpret complex legal contracts and communicate key issues to sponsor clients.
    • Strong understanding of legal issues and risks pertaining to clinical research contract drafting and administration.
    • Knowledge of medical terminology and coding methodologies preferred. Familiarity with family of medical code systems, HCPCS, CPT, RBRVS, ICD-10CM/PCS, DRGs preferred. MCRA will incorporate basic training into position responsibilities when required.
    • Knowledge of clinical trial management, billing code systems and claims processing.
    • Proficiency with MS Office Suite and internet applications.
    • Ability to work on activities 3-5 studies at any given time.
    • Understanding of medical terminology and confidence when speaking with investigators and medical staff. 
    • Excellent quantitative and analytical skills.
    • Ability to work independently and handle confidential information. 
    • Excellent oral and written communication skills with experience in presenting analysis to clients.
    • Travel up to 10%

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