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 Associate
NeuMoDx is seeking a highly motivated individual to serve the role of a Clinical Research Associate (CRA) and be a key member assisting the clinical study team with all operational activities for new and on-going clinical research projects. The ideal candidate must be results oriented, demonstrate excellent interpersonal skills, and possess strong attention to detail in order to assist in the design, planning, and execution of molecular diagnostic product related clinical evaluations in accordance with all applicable regulations.
- Ensure clinical research projects are conducted, recorded, and reported in accordance with approved protocols, FDA Regulations, ICH-GCP compliance, company SOPs and client guidelines
- Effectively identify and liaise with physicians, investigators and study personnel conducting the trial to ensure effective execution of clinical study protocols
- Identify, in a timely manner, issues that could potentially affect study results or on-time completion of study, or any protocol deviation, and suggest means of resolving such issues
- Conduct on-site visits and complete associated reports for site qualification, site initiation, interim monitoring and site closeout, which will include the following:
- Train on-site personnel on the use of the NeuMoDx Systems and associated assays as well as study protocols, including CRF completion, event reporting, etc.
- Perform source document verification where required, retrieve Case Report Forms (CRFs) and perform query resolution in a timely manner
- Author, file, and collate study documentation, including all site correspondence, to compile the Trial Master File (TMF)
- Assists in the development of the clinical research infrastructure including standard operating procedures, work instructions, templates and forms applicable to on-site visits
- Assists in the compilation of clinical related data to the FDA and EU regulatory bodies
Essential Knowledge and Skills:
- Minimum Bachelor’s degree required in a clinical, scientific, healthcare, or related field
- A minimum of 5 years as a clinical research associate conducting on-site visits, preferably for in vitro diagnostic product evaluations. Will consider a work history involving IVD lab experience along with pharmaceutical or medical device field monitoring.
- Working knowledge of GCP/ICH guidelines and FDA regulations
- A sound understanding of statistics and clinical trial design is desirable
- Working knowledge of molecular diagnostics is highly desirable
- Can-do attitude with a willingness to go the extra mile to ensure project success with minimal oversight
- Excellent communication (written & verbal) and interpersonal skills – including negotiating and ability to build effective relationships with study site staff and colleagues
- Exceptional organizational, planning, and administrative skills/eye for detail – the job involves a lot of documentation and recording of information that must be accurate and thorough
- Ability to prioritize, multi-task, and think on your feet in a fast-paced work environment
- CRA or CRC certification preferred.
In-house position with extensive travel (50-60%) required within U.S. and possibly internationally. 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.