NeuMoDx Molecular Inc. (“NMDX”) designs and develops revolutionary molecular diagnostic solutions for hospital and clinical reference laboratories. Our patented, ‘sample-to-result’ platform offers market-leading ease of use, true continuous random-access, and rapid turnaround time while achieving optimal operational and clinical performance for our customers and the patients they serve. In addition to focusing design and development efforts on tests to detect Sexually Transmitted and Infectious Diseases, NMDX has developed and will commercialize a broad range of general purpose reagents and consumables for use by customers in developing qualitative and quantitative Laboratory Developed Tests (LDTs) for use with the NMDX Molecular Systems to detect and amplify DNA and RNA targets.
Clinical Research Specialist
NeuMoDx is seeking a highly motivated individual to serve as a Clinical Research Specialist to assist the clinical study team with all operational activities to assist in the design, planning, and execution of molecular diagnostic product related clinical evaluations in accordance with all applicable regulations. The ideal candidate must be an effective communicator (written and verbal), a critical thinker and possess a strong attention to detail and order.
- Ensure clinical research projects are conducted, recorded, and reported in accordance with approved protocols, and all applicable regulatory requirements
- Assist in the development of the clinical research infrastructure, which may include standard operating procedures, work instructions, templates and forms
- Draft clinical study protocols with direction from higher level
- Coordinate with CROs and respond to clinical site inquiries
- Create study specific essential documents lists that meet regulatory requirements
- Conduct in-house and site (if applicable) reviews of associated documentation to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, internal SOPs, as well as US and OUS regulations
- Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas
- Determine or effectively recommend course of action after considering potential risks of alternatives
- Make decisions in the face of different alternatives and guidelines or with guidelines that are not complete and exhaustive, and which allow room for creativity and judgment
Experience and Qualifications:
- Bachelor’s degree (minimum) in a clinical, scientific, healthcare, or related field
- Minimum 3 years of experience working with clinical studies
- Clinical background, familiar with clinical study processes relevant to ICH GCP (E6) guidelines
- Working experience with CROs for clinical trials conduct
- Medical device – specifically in vitro diagnostic (IVD) product clinical study experience
- Ability to interpret and apply applicable procedures, regulatory requirements, guidelines and standards to various projects
- Working knowledge of MS Office Suite and eTMF (electronic Trial Master file) preferred
- Solid knowledge and understanding of company policies, procedures, as well as international and domestic medical device regulatory guidelines relevant to clinical protocols
- Working knowledge of molecular diagnostics is highly desirable
- Excellent critical thinking and problem-solving skills
- Ability to prioritize in a fast-paced work environment and work independently without close supervision
- Exceptional written and verbal communication skills, including a knack for technical writing
- Abiltity to work effectively in a cross-functional team setting and build interpersonal relationships
Candidates must be able to work in the U.S. on an unrestricted basis and have a good driving record.
NMDx offers an entrepreneurial working environment and a competitive salary and benefits package featuring paid time off, 401k with company match, disability insurance, and medical/dental plans.
For consideration, please submit CV & salary requirements to firstname.lastname@example.org and mention the job description in the subject. No phone calls please. Only qualified candidates will be contacted.